{"data":{"id":"us/21-cfr-310.545","jurisdiction":"us","citation":"21 CFR 310.545","heading":"Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.","body":"(a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:\n(1) Topical acne drug products.\nAlcloxa\nAlkyl isoquinolinium bromide\nAluminum chlorohydrex\nAluminum hydroxide\nBenzocaine\nBenzoic acid\nBoric acid\nCalcium polysulfide\nCalcium thiosulfate\nCamphor\nChloroxylenol\nCloxyquin\nCoal tar\nDibenzothiophene\nEstrone\nMagnesium aluminum silicate\nMagnesium sulfate\nPhenol\nPhenolate sodium\nPhenyl salicylate\nPovidone-iodine\nPyrilamine maleate\nResorcinol (as single ingredient)\nResorcinol monoacetate (as single ingredient)\nSalicylic acid (over 2 up to 5 percent)\nSodium borate\nSodium thiosulfate\nTetracaine hydrochloride\nThymol\nVitamin E\nZinc oxide\nZinc stearate\nZinc sulfide\n(2) Anticaries drug products—(i) Approved as of May 7, 1991.\nHydrogen fluoride\nSodium carbonate\nSodium monofluorophosphate (6 percent rinse)\nSodium phosphate\n(ii) Approved as of October 7, 1996.\nCalcium sucrose phosphate\nDicalcium phosphate dihydrate\nDisodium hydrogen phosphate 1\nPhosphoric acid 1\nSodium dihydrogen phosphate\nSodium dihydrogen phosphate monohydrate\nSodium phosphate, dibasic anhydrous reagent 1\n(3) Antidiarrheal drug products—(i) Approved as of May 7, 1991.\nAluminum hydroxide\nAtropine sulfate\nCalcium carbonate\nCarboxymethylcellulose sodium\nGlycine\nHomatropine methylbromide\nHyoscyamine sulfate\nLactobacillus acidophilus\nLactobacillus bulgaricus\nOpium, powdered\nOpium tincture\nParegoric\nPhenyl salicylate\nScopolamine hydrobromide\nZinc phenolsulfonate\n(ii) Approved as of April 19, 2004; April 18, 2005, for products with annual sales less than $25,000.\nAttapulgite, activated\nBismuth subnitrate\nCalcium hydroxide\nCalcium polycarbophil\nCharcoal (activated)\nPectin\nPolycarbophil\nPotassium carbonate\nRhubarb fluidextract\n(4) Antiperspirant drug products—(i) Ingredients—Approved as of May 7, 1991.\nAlum, potassium\nAluminum bromohydrate\nAluminum chloride (alcoholic solutions)\nAluminum chloride (aqueous solution) (aerosol only)\nAluminum sulfate\nAluminum sulfate, buffered (aerosol only)\nSodium aluminum chlorohydroxy lactate\n(ii) Approved as of December 9, 2004; June 9, 2005, for products with annual sales less than $25,000.\nAluminum sulfate buffered with sodium aluminum lactate\n(5) [Reserved]\n(6) Cold, cough, allergy, bronchodilator, and antiasthmatic drug products—(i) Antihistamine drug products—(A) Ingredients.\nMethapyrilene hydrochloride\nMethapyrilene fumarate\nThenyldiamine hydrochloride\n(B) Ingredients.\nPhenyltoloxamine dihydrogen citrate\nMethapyrilene hydrochloride\nMethapyrilene fumarate\nThenyldiamine hydrochloride\n(ii) Nasal decongestant drug products—(A) Approved as of May 7, 1991.\nAllyl isothiocyanate\nCamphor (lozenge)\nCreosote, beechwood (oral)\nEucalyptol (lozenge)\nEucalyptol (mouthwash)\nEucalyptus oil (lozenge)\nEucalyptus oil (mouthwash)\nMenthol (mouthwash)\nPeppermint oil (mouthwash)\nThenyldiamine hydrochloride\nThymol\nThymol (lozenge)\nThymol (mouthwash)\nTurpentine oil\n(B) Approved as of August 23, 1995.\nBornyl acetate (topical)\nCedar leaf oil (topical)\nCreosote, beechwood (topical)\nEphedrine (oral)\nEphedrine hydrochloride (oral)\nEphedrine sulfate (oral)\nRacephedrine hydrochloride (oral/topical)\n(C) Approved as of April 11, 2007; October 11, 2007, for products with annual sales less than $25,000. Any ingredient(s) labeled with claims or directions for use for sinusitis or for relief of nasal congestion associated with sinusitis.\n(iii) Expectorant drug products.\nAmmonium chloride\nAntimony potassium tartrate\nBeechwood creosote\nBenzoin preparations (compound tincture of benzoin, tincture of benzoin)\nCamphor\nChloroform\nEucalyptol/eucalyptus oil\nHorehound\nIodides (calcium iodide anyhydrous, hydroidic acid syrup, iodized lime, potassium iodide)\nIpecac\nIpecac fluidextract\nIpecac syrup\nMenthol/peppermint oil\nPine tar preparations (extract white pine compound, pine tar, syrup of pine tar, compound white pine syrup, white pine)\nPotassium guaiacolsulfonate\nSodium citrate\nSquill preparations (squill, squill extract)\nTerpin hydrate preparations (terpin hydrate, terpin hydrate elixir)\nTolu preparations (tolu, tolu balsam, tolu balsam tincture)\nTurpentine oil (spirits of turpentine)\n(iv) Bronchodilator drug products—(A) Approved as of October 2, 1987.\nAminophylline\nBelladonna alkaloids\nEuphorbia pilulifera\nMetaproterenol sulfate\nMethoxyphenamine hydrochloride\nPseudoephedrine hydrochloride\nPseudoephedrine sulfate\nTheophylline, anhydrous\nTheophylline calcium salicylate\nTheophylline sodium glycinate\n(B) Approved as of January 29, 1996. Any combination drug product containing theophylline (e.g., theophylline and ephedrine, or theophylline and ephedrine and phenobarbital).\n(C) Approved as of June 19, 1996. Any ingredient(s) in a pressurized metered-dose inhaler container.\n(D) Approved as of October 29, 2001. Any oral bronchodilator active ingredient (e.g., ephedrine, ephedrine hydrochloride, ephedrine sulfate, racephedrine hydrochloride, or any other ephedrine salt) in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient.\n(7) Dandruff/seborrheic dermatitis/psoriasis drug products.\nAlkyl isoquinolinium bromide\nAllantoin\nBenzalkonium chloride\nBenzethonium chloride\nBoric acid\nCalcium undecylenate\nCaptan\nChloroxylenol\nColloidal oatmeal\nCresol, saponated\nEthohexadiol\nEucalyptol\nJuniper tar\nLauryl isoquinolinium bromide\nMenthol\nMercury oleate\nMethylbenzethonium chloride\nMethyl salicylate\nPhenol\nPhenolate sodium\nPine tar\nPovidone-iodine\nResorcinol\nSodium borate\nSodium salicylate\nThymol\nUndecylenic acid\n(8) Digestive aid drug products—(i) Approved as of May 7, 1991.\nBismuth sodium tartrate\nCalcium carbonate\nCellulase\nDehydrocholic acid\nDihydroxyaluminum sodium carbonate\nDuodenal substance\nGarlic, dehydrated\nGlutamic acid hydrochloride\nHemicellulase\nHomatropine methylbromide\nMagnesium hydroxide\nMagnesium trisilicate\nOx bile extract\nPancreatin\nPancrelipase\nPapain\nPeppermint oil\nPepsin\nSodium bicarbonate\nSodium citrate\nSorbitol\n(ii) Approved as of November 10, 1993.\nAlcohol\nAluminum hydroxide\nAmylase\nAnise seed\nAromatic powder\nAsafetida\nAspergillus oryza enzymes (except lactase enzyme derived from Aspergillus oryzae)\nBacillus acidophilus\nBean\nBelladonna alkaloids\nBelladonna leaves, powdered extract\nBetaine hydrochloride\nBismuth subcarbonate\nBismuth subgallate\nBlack radish powder\nBlessed thistle (cnicus benedictus)\nBuckthorn\nCalcium gluconate\nCapsicum\nCapsicum, fluid extract of\nCarbon\nCascara sagrada extract\nCatechu, tincture\nCatnip\nChamomile flowers\nCharcoal, wood\nChloroform\nCinnamon oil\nCinnamon tincture\nCitrus pectin\nDiastase\nDiastase malt\nDog grass\nElecampane\nEther\nFennel acid\nGalega\nGinger\nGlycine\nHydrastis canadensis (golden seal)\nHectorite\nHorsetail\nHuckleberry\nHydrastis fluid extract\nHydrochloric acid\nIodine\nIron ox bile\nJohnswort\nJuniper\nKaolin, colloidal\nKnotgrass\nLactic acid\nLactose\nLavender compound, tincture of\nLinden\nLipase\nLysine hydrochloride\nMannitol\nMycozyme\nMyrrh, fluid extract of\nNettle\nNickel-pectin\nNux vomica extract\nOrthophosphoric acid\nPapaya, natural\nPectin\nPeppermint\nPeppermint spirit\nPhenacetin\nPotassium bicarbonate\nPotassium carbonate\nProtease\nProlase\nRhubarb fluid extract\nSenna\nSodium chloride\nSodium salicylate\nStem bromelain\nStrawberry\nStrychnine\nTannic acid\nTrillium\nWoodruff\n(iii) Charcoal, activated\n(9) [Reserved]\n(10) External analgesic drug products—(i) Analgesic and anesthetic drug products.\nAspirin\nChloral hydrate\nChlorobutanol\nCyclomethycaine sulfate\nEugenol\nHexylresorcinol\nMethapyrilene hydrochloride\nSalicylamide\nThymol\n(ii) Counterirritant drug products.\nChloral hydrate\nEucalyptus oil\n(iii) Male genital desensitizer drug products.\nBenzyl alcohol\nCamphorated metacresol\nEphedrine hydrochloride\n(iv) Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.\n(v) Fever blister and cold sore treatment drug products.\nAllyl isothiocyanate\nAspirin\nBismuth sodium tartrate\nCamphor (exceeding 3 percent)\nCapsaicin\nCapsicum\nCapsicum oleoresin\nChloral hydrate\nChlorobutanol\nCyclomethycaine sulfate\nEucalyptus oil\nEugenol\nGlycol salicylate\nHexylresorcinol\nHistamine dihydrochloride\nMenthol (exceeding 1 percent)\nMethapyrilene hydrochloride\nMethyl nicotinate\nMethyl salicylate\nPectin\nSalicylamide\nStrong ammonia solution\nTannic acid\nThymol\nTripelennamine hydrochloride\nTrolamine salicylate\nTurpentine oil\nZinc sulfate\n(vi) Insect bite and sting drug products.\nAlcohol\nAlcohol, ethoxylated alkyl\nBenzalkonium chloride\nCalamine\nErgot fluidextract\nFerric chloride\nPanthenol\nPeppermint oil\nPyrilamine maleate\nSodium borate\nTrolamine salicylate\nTurpentine oil\nZinc oxide\nZirconium oxide\n(vii) Poison ivy, poison oak, and poison sumac drug products.\nAlcohol\nAspirin\nBenzethonium chloride\nBenzocaine (0.5 to 1.25 percent)\nBithionol\nCalamine\nCetalkonium chloride\nChloral hydrate\nChlorobutanol\nChlorpheniramine maleate\nCreosote, beechwood\nCyclomethycaine sulfate\nDexpanthenol\nDiperodon hydrochloride\nEucalyptus oil\nEugenol\nGlycerin\nGlycol salicylate\nHectorite\nHexylresorcinol\nHydrogen peroxide\nImpatiens biflora tincture\nIron oxide\nIsopropyl alcohol\nLanolin\nLead acetate\nMerbromin\nMercuric chloride\nMethapyrilene hydrochloride\nPanthenol\nParethoxycaine hydrochloride\nPhenyltoloxamine dihydrogen citrate\nPovidone-vinylacetate copolymers\nPyrilamine maleate\nSalicylamide\nSalicylic acid\nSimethicone\nSulfur\nTannic acid\nThymol\nTrolamine salicylate\nTurpentine oil\nZirconium oxide\nZyloxin\n(11) [Reserved]\n(12) Laxative drug products—(i)(A) Bulk laxatives.\nAgar\nCarrageenan (degraded)\nCarrageenan (native)\nGuar gun\n(i)(B) Bulk laxatives—Approved as of March 29, 2007.\nGranular dosage forms containing psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago husks, or plantago seed including, but not limited to, any granules that are:\n(1) Swallowed dry prior to drinking liquid,\n(2) Dispersed, suspended, or partially dissolved in liquid prior to swallowing,\n(3) Chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid, or\n(4) Sprinkled over food.\n(ii) Saline laxative.\nTartaric acid\n(iii) Stool softener.\nPoloxamer 188\n(iv)(A) Stimulant laxatives—Approved as of May 7, 1991.\nAloin\nBile salts/acids\nCalcium pantothenate\nCalomel\nColocynth\nElaterin resin\nFrangula\nGamboge\nIpomea\nJalap\nOx bile\nPodophyllum resin\nPrune concentrate dehydrate\nPrune powder\nRhubarb, Chinese\nSodium Oleate\n(iv)(B) Stimulant laxatives—Approved as of January 29, 1999.\nDanthron\nPhenolphthalein\n(C) Stimulant laxatives—Approved as of November 5, 2002.\nAloe ingredients (aloe, aloe extract, aloe flower extract)\nCascara sagrada ingredients (casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, cascara sagrada fluidextract).\n(13) [Reserved]\n(14) Oral health care drug products (nonantimicrobial).\nAntipyrine\nCamphor\nCresol\nDibucaine\nDibucaine hydrochloride\nEucalyptol\nLidocaine\nLidocaine hydrochloride\nMethly salicylate\nMyrrh tincture\nPyrilamine maleate\nSorbitol\nSugars\nTetracaine\nTetracaine hydrochloride\nThymol\n(15) Topical otic drug products—(i) For the prevention of swimmer's ear and for the drying of water-clogged ears, approved as of May 7, 1991.\nAcetic acid\n(ii) For the prevention of swimmer's ear, approved as of August 15, 1995.\nGlycerin and anhydrous glycerin\nIsopropyl alcohol\n(16) Poison treatment drug products.\nIpecac fluidextract\nIpecac tincture\nZinc sulfate\n(17) Skin bleaching drug products.\nMercury, ammoniated\n(18) Skin protectant drug products—(i)(A) Ingredients—Approved as of May 7, 1991.\nAllantoin (wound healing claims only)\nSulfur\nTannic acid\nZinc acetate (wound healing claims only)\n(B) Ingredients—Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.\nBeeswax\nBismuth subnitrate\nBoric acid\nCetyl alcohol\nGlyceryl stearate\nIsopropyl palmitate\nLive yeast cell derivative\nShark liver oil\nStearyl alcohol\n(ii) Astringent drug products.\nAcetone\nAlcohol\nAlum, ammonium\nAlum, potassium\nAluminum chlorhydroxy complex\nAromatics\nBenzalkonium chloride\nBenzethonium chloride\nBenzocaine\nBenzoic acid\nBoric acid\nCalcium acetate (except calcium acetate monohydrate when combined with aluminum sulfate tetradecahydrate to provide an aluminum acetate solution as described in § 347.20(b) of this chapter)\nCamphor gum\nClove oil\nColloidal oatmeal\nCresol\nCupric sulfate\nEucalyptus oil\nEugenol\nFerric subsulfate (Monsel's Solution)\nHoney\nIsopropyl alcohol\nMenthol\nMethyl salicylate\nOxyquinoline sulfate\nP-t-butyl-m-cresol\nPeppermint oil\nPhenol\nPolyoxeythylene laurate\nPotassium ferrocyanide\nSage oil\nSilver nitrate\nSodium borate\nSodium diacetate\nTalc\nTannic acid glycerite\nThymol\nTopical starch\nZinc chloride\nZinc oxide\nZinc phenolsulfonate\nZinc stearate\nZinc sulfate\n(iii) Diaper rash drug products.\nAluminum hydroxide\nCocoa butter\nCysteine hydrochloride\nGlycerin\nProtein hydrolysate\nRacemethionine\nSulfur\nTannic acid\nZinc acetate\nZinc carbonate\n(iv) Fever blister and cold sore treatment drug products.\nBismuth subnitrate\nBoric acid\nPyridoxine hydrochloride\nSulfur\nTannic acid\nTopical starch\nTrolamine\nZinc sulfate\n(v) Insect bite and sting drug products—(A) Ingredients—Approved as of November 10, 1993.\nAlcohol\nAlcohol, ethoxylated alkyl\nAmmonia solution, strong\nAmmonium hydroxide\nBenzalkonium chloride\nCamphor\nErgot fluid extract\nFerric chloride\nMenthol\nPeppermint oil\nPhenol\nPyrilamine maleate\nSodium borate\nTrolamine\nTurpentine oil\nZirconium oxide\n(B) Ingredients—Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.\nBeeswax\nBismuth subnitrate\nBoric acid\nCetyl alcohol\nGlyceryl stearate\nIsopropyl palmitate\nLive yeast cell derivative\nShark liver oil\nStearyl alcohol\n(vi) Poison ivy, poison oak, and poison sumac drug products—(A) Ingredients—Approved as of November 10, 1993.\nAlcohol\nAnion and cation exchange resins buffered\nBenzethonium chloride\nBenzocaine\nBenzyl alcohol\nBismuth subnitrate\nBithionol\nBoric acid\nCamphor\nCetalkonium chloride\nChloral hydrate\nChlorpheniramine maleate\nCreosote\nDiperodon hydrochloride\nDiphenhydramine hydrochloride\nEucalyptus oil\nFerric chloride\nGlycerin\nHectorite\nHydrogen peroxide\nImpatiens biflora tincture\nIron oxide\nIsopropyl alcohol\nLanolin\nLead acetate\nLidocaine\nMenthol\nMerbromin\nMercuric chloride\nPanthenol\nParethoxycaine hydrochloride\nPhenol\nPhenyltoloxamine dihydrogen citrate\nPovidone-vinylacetate copolymers\nSalicylic acid\nSimethicone\nTannic acid\nTopical starch\nTrolamine\nTurpentine oil\nZirconium oxide\nZyloxin\n(B) Ingredients—Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.\nBeeswax\nBismuth subnitrate\nBoric acid\nCetyl alcohol\nGlyceryl stearate\nIsopropyl palmitate\nLive yeast cell derivative\nShark liver oil\nStearyl alcohol\n(19) [Reserved]\n(20) Weight control drug products.\nAlcohol\nAlfalfa\nAlginic acid\nAnise oil\nArginine\nAscorbic acid\nBearberry\nBiotin\nBone marrow, red\nBuchu\nBuchu, potassium extract\nCaffeine\nCaffeine citrate\nCalcium\nCalcium carbonate\nCalcium caseinate\nCalcium lactate\nCalcium pantothenate\nCarboxymethylcellulose sodium\nCarrageenan\nCholecalcierol\nCholine\nChondrus\nCitric acid\nCnicus benedictus\nCopper\nCopper gluconate\nCorn oil\nCorn syrup\nCorn silk, potassium extract\nCupric sulfate\nCyanocobalamin (vitamin B12)\nCystine\nDextrose\nDocusate sodium\nErgocalciferol\nFerric ammonium citrate\nFerric pyrophosphate\nFerrous fumarate\nFerrous gluconate\nFerrous sulfate (iron)\nFlax seed\nFolic acid\nFructose\nGuar gum\nHistidine\nHydrastis canadensis\nInositol\nIodine\nIsoleucine\nJuniper, potassium extract\nKaraya gum\nKelp\nLactose\nLecithin\nLeucine\nLiver concentrate\nLysine\nLysine hydrochloride\nMagnesium\nMagnesium oxide\nMalt\nMaltodextrin\nManganese citrate\nMannitol\nMethionine\nMethylcellulose\nMono- and di-glycerides\nNiacinamide\nOrganic vegetables\nPancreatin\nPantothenic acid\nPapain\nPapaya enzymes\nPepsin\nPhenacetin\nPhenylalanine\nPhosphorus\nPhytolacca\nPineapple enzymes\nPlantago seed\nPotassium citrate\nPyridoxine hydrochloride (vitamin B6)\nRiboflavin\nRice polishings\nSaccharin\nSea minerals\nSesame seed\nSodium\nSodium bicarbonate\nSodium caseinate\nSodium chloride (salt)\nSoybean protein\nSoy meal\nSucrose\nThiamine hydrochloride (vitamin B1)\nThiamine mononitrate (vitamin B1 mononitrate)\nThreonine\nTricalcium phosphate\nTryptophan\nTyrosine\nUva ursi, potassium extract\nValine\nVegetable\nVitamin A\nVitamin A acetate\nVitamin A palmitate\nVitamin E\nWheat germ\nXanthan gum\nYeast\n(21) Ophthalmic drug products. (i) Ophthalmic anesthetic drug products.\nAntipyrine\nPiperocaine hydrochloride\n(ii) Ophthalmic anti-infective drug products.\nBoric acid\nMild silver protein\nYellow mercuric oxide\n(iii) Ophthalmic astringent drug products.\nInfusion of rose petals\n(iv) Ophthalmic demulcent drug products.\nPolyethylene glycol 6000\n(v) Ophthalmic vasoconstrictor drug products.\nPhenylephrine hydrochloride (less than 0.08 percent)\n(22) Topical antifungal drug products. (i) Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.\n(ii) Ingredients.\nAlcloxa\nAlum, potassium\nAluminum sulfate\nAmyltricresols, secondary\nBasic fuchsin\nBenzethonium chloride\nBenzoic acid\nBenzoxiquine\nBoric acid\nCamphor\nCandicidin\nChlorothymol\nCoal tar\nDichlorophen\nMenthol\nMethylparaben\nOxyquinoline\nOxyquinoline sulfate\nPhenol\nPhenolate sodium\nPhenyl salicylate\nPropionic acid\nPropylparaben\nResorcinol\nSalicylic acid\nSodium borate\nSodium caprylate\nSodium propionate\nSulfur\nTannic acid\nThymol\nTolindate\nTriacetin\nZinc caprylate\nZinc propionate\n(iii) Any ingredient(s) labeled with claims or directions for use on the scalp or on the nails.\n(iv) Ingredients.\nCamphorated metacresol\nChloroxylenol\nm-cresol\nNystatin\n(23) Internal analgesic drug products—(i) Approved as of November 10, 1993.\nAminobenzoic acid\nAntipyrine\nAspirin, aluminum\nCalcium salicylate\nCodeine\nCodeine phosphate\nCodeine sulfate\nIodoantipyrine\nLysine aspirin\nMethapyrilene fumarate\nPhenacetin\nPheniramine maleate\nPyrilamine maleate\nQuinine\nSalsalate\nSodium aminobenzoate\n(ii) Approved as of February 22, 1999.\nAny atropine ingredient\nAny ephedrine ingredient\n(24) Orally administered menstrual drug products—(i) Approved as of November 10, 1993.\nAlcohol\nAlfalfa leaves\nAloes\nAsclepias tuberosa\nAsparagus\nBarosma\nBearberry (extract of uva ursi)\nBearberry fluidextract (extract of bearberry)\nBlessed thistle (cnicus benedictus)\nBuchu powdered extract (extract of buchu)\nCalcium lactate\nCalcium pantothenate\nCapsicum oleoresin\nCascara fluidextract, aromatic (extract of cascara)\nChlorprophenpyridamine maleate\nCimicifuga racemosa\nCodeine\nCollinsonia (extract stone root)\nCorn silk\nCouch grass\nDog grass extract\nEthyl nitrite\nFerric chloride\nFerrous sulfate\nGentiana lutea (gentian)\nGlycyrrhiza (licorice)\nHomatropine methylbromide\nHydrangea, powdered extract (extract of hydrangea)\nHydrastis canadensis (golden seal)\nHyoscyamine sulfate\nJuniper oil (oil of juniper)\nMagnesium sulfate\nMethapyrilene hydrochloride\nMethenamine\nMethylene blue\nNatural estrogenic hormone\nNiacinamide\nNutmeg oil (oil of nutmeg)\nOil of erigeron\nParsley\nPeppermint spirit\nPepsin, essence\nPhenacetin\nPhenindamine tartrate\nPhenyl salicylate\nPiscidia erythrina\nPipsissewa\nPotassium acetate\nPotassium nitrate\nRiboflavin\nSaw palmetto\nSenecio aureus\nSodium benzoate\nSodium nitrate\nSucrose\nSulferated oils of turpentine\nTaraxacum officinale\nTheobromine sodium salicylate\nTheophylline\nThiamine hydrochloride\nTriticum\nTurpentine, venice (venice turpertine)\nUrea\n(ii) Approved as of February 22, 1999.\nAny atropine ingredient\nAny ephedrine ingredient\n(25) Pediculicide drug products—(i) Approved as of November 10, 1993.\nBenzocaine\nBenzyl alcohol\nBenzyl benzoate\nChlorophenothane (dichlorodiphenyl trichloroethane)\nCoconut oil soap, aqueous\nCopper oleate\nDocusate sodium\nFormic acid\nIsobornyl thiocyanoacetate\nPicrotoxin\nPropylene glycol\nSabadilla alkaloids\nSulfur, sublimed\nThiocyanoacetate\n(ii) Approved as of June 14, 1994. The combination of pyrethrum extract (formerly named pyrethrins) and piperonyl butoxide in an aerosol dosage formulation.\n(26) Anorectal drug products—(i) Anticholinergic drug products.\nAtropine\nBelladonna extract\n(ii) Antiseptic drug products.\nBoric acid\nBoroglycerin\nHydrastis\nPhenol\nResorcinol\nSodium salicylic acid phenolate\n(iii) Astringent drug products.\nTannic acid\n(iv) Counterirritant drug products.\nCamphor (greater than 3 to 11 percent)\nHydrastis\nMenthol (1.25 to 16 percent)\nTurpentine oil (rectified) (6 to 50 percent)\n(v) Keratolytic drug products.\nPrecipitated sulfur\nSublimed sulfur\n(vi) Local anesthetic drug products.\nDiperodon\nPhenacaine hydrochloride\n(vii) Other drug products.\nCollinsonia extract\nEscherichia coli vaccines\nLappa extract\nLeptandra extract\nLive yeast cell derivative\nMullein\n(viii) Protectant drug products.\nBismuth oxide\nBismuth subcarbonate\nBismuth subgallate\nBismuth subnitrate\nLanolin alcohols\n(ix) Vasoconstrictor drug products.\nEpinephrine undecylenate\n(x) Wound healinq drug products.\nCholecalciferol\nCod liver oil\nLive yeast cell derivative\nPeruvian balsam\nShark liver oil\nVitamin A\n(xi) Combination drug products. Any combination drug product containing hydrocortisone and pramoxine hydrochloride.\n(27) Topical antimicrobial drug products—(i) First aid antiseptic drug products.\nAmmoniated mercury\nCalomel (mercurous chloride)\nMerbromin (mercurochrome)\nMercufenol chloride (ortho-chloromercuriphenol, ortho-hydroxyphenylmercuric chloride)\nMercuric chloride (bichloride of mercury, mercury chloride)\nMercuric oxide, yellow\nMercuric salicylate\nMercuric sulfide, red\nMercury\nMercury oleate\nMercury sulfide\nNitromersol\nPara-chloromercuriphenol\nPhenylmercuric nitrate\nThimerosal\nVitromersol\nZyloxin\n(ii) Diaper rash drug products.\nPara-chloromercuriphenol\nAny other ingredient containing mercury\n(iii) Consumer antiseptic hand wash drug products. Approved as of September 6, 2017.\nCloflucarban\nFluorosalan\nHexachlorophene\nHexylresorcinol\nIodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)\nIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)\nMethylbenzethonium chloride\nNonylphenoxypoly (ethyleneoxy) ethanoliodine\nPhenol (greater than 1.5 percent)\nPhenol (less than 1.5 percent)\nPoloxamer iodine complex\nPovidone-iodine (5 to 10 percent)\nSecondary amyltricresols\nSodium oxychlorosene\nTribromsalan\nTriclocarban\nTriclosan\nTriple Dye\nUndecoylium chloride iodine complex\n(iv) Consumer antiseptic body wash drug products. Approved as of September 6, 2017.\nCloflucarban\nFluorosalan\nHexachlorophene\nHexylresorcinol\nIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)\nIodine tincture\nMethylbenzethonium chloride\nNonylphenoxypoly (ethyleneoxy) ethanoliodine\nPhenol (greater than 1.5 percent)\nPhenol (less than 1.5 percent)\nPoloxamer iodine complex\nPovidone-iodine (5 to 10 percent)\nSecondary amyltricresols\nSodium oxychlorosene\nTribromsalan\nTriclocarban\nTriclosan\nTriple Dye\nUndecoylium chloride iodine complex\n(v) [Reserved]\n(vi) Health care personnel hand wash drug products. Approved as of December 20, 2018.\nCloflucarban\nFluorosalan\nHexachlorophene\nHexylresorcinol\nIodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)\nIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)\nMethylbenzethonium chloride\nNonylphenoxypoly (ethyleneoxy) ethanoliodine\nPhenol\nPoloxamer-iodine complex\nSecondary amyltricresols\nSodium oxychlorosene\nTribromsalan\nTriclocarban\nTriclosan\nUndecoylium chloride iodine complex\n(vii) [Reserved]\n(viii) Surgical hand scrub drug products. Approved as of December 20, 2018.\nCloflucarban\nFluorosalan\nHexachlorophene\nHexylresorcinol\nIodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)\nIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)\nMethylbenzethonium chloride\nNonylphenoxypoly (ethyleneoxy) ethanoliodine\nPhenol\nPoloxamer-iodine complex\nSecondary amyltricresols\nSodium oxychlorosene\nTribromsalan\nTriclocarban\nTriclosan\nUndecoylium chloride iodine complex\n(ix) [Reserved]\n(x) Patient antiseptic skin preparation drug products. Approved as of December 20, 2018.\nCloflucarban\nFluorosalan\nHexachlorophene\nHexylresorcinol\nIodine complex (phosphate ester of alkylaryloxy polyethylene glycol)\nIodine tincture (USP)\nIodine topical solution (USP)\nMercufenol chloride\nMethylbenzethonium chloride\nNonylphenoxypoly (ethyleneoxy) ethanoliodine\nPhenol\nPoloxamer-iodine complex\nSecondary amyltricresols\nSodium oxychlorosene\nTribromsalan\nTriclocarban\nTriclosan\nTriple dye\nUndecoylium chloride iodine complex\nCombination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative\nCombination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol\n(28) Vaginal contraceptive drug products—(i) Approved as of October 22, 1998.\nDodecaethylene glycol monolaurate (polyethylene glycol 600 monolaurate)\nLaureth 10S\nMethoxypolyoxyethyleneglycol 550 laurate\nPhenylmercuric acetate\nPhenylmercuric nitrate\nAny other ingredient containing mercury\n(ii) Approved as of November 5, 2002.\nOctoxynol 9\n(29) Sunscreen drug products. (i) Ingredients.\nDiethanolamine methoxycinnamate\nDigalloyl trioleate\nEthyl 4-[bis(hydroxypropyl)] aminobenzoate\nGlyceryl aminobenzoate\nLawsone with dihydroxyacetone\nRed petrolatum\n(ii) Any ingredients labeled with any of the following or similar claims. Instant protection or protection immediately upon application.\nClaims for “all-day” protection or extended wear claims citing a specific number of hours of protection that is inconsistent with the directions for application in 21 CFR 201.327.\n(30) [Reserved]\n(b) Any OTC drug product that is labeled, represented, or promoted for the uses specified and containing any active ingredient(s) as specified in paragraph (a) of this section is regarded as a new drug within the meaning of section 210(p) of the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the Act.\n(c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for the OTC uses and containing any active ingredient(s) as specified in paragraph (a) of this section is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.\n(d) Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(42) of this section.\n(1) May 7, 1991, for products subject to paragraphs (a)(1) through (a)(2)(i), (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7) (except as covered by paragraph (d)(3) of this section), (a)(8)(i), (a)(10)(i) through (a)(10)(iii), (a)(12)(i)(A), (a)(12)(ii) through (a)(12)(iv)(A), (a)(14) through (a)(15)(i), (a)(16) through (a)(18)(i)(A), (a)(18)(ii) (except as covered by paragraph (d)(22) of this section), (a)(18)(iii), (a)(18)(iv), (a)(18)(v)(A), and (a)(18)(vi)(A) of this section.\n(2) February 10, 1992, for products subject to paragraph (a)(20) of this section.\n(3) December 4, 1992, for products subject to paragraph (a)(7) of this section that contain menthol as an antipruritic in combination with the antidandruff ingredient coal tar identified in § 358.710(a)(1) of this chapter. This section does not apply to products allowed by § 358.720(b) of this chapter after April 5, 2007.\n(4) February 28, 1990, for products subject to paragraph (a)(6)(iii) of this section, except those that contain ipecac.\n(5) September 14, 1993, for products subject to paragraph (a)(6)(iii) of this section that contain ipecac.\n(6) December 9, 1993, for products subject to paragraph (a)(6)(i)(B) of this section.\n(7) March 6, 1989, for products subject to paragraph (a)(21) of this section, except those that contain ophthalmic anti-infective ingredients listed in paragraph (a)(21)(ii).\n(8) June 18, 1993, for products subject to paragraph (a)(21) of this section that contain ophthalmic anti-infective ingredients.\n(9) June 18, 1993, for products subject to paragraph (a)(10)(iv) of this section.\n(10) June 18, 1993, for products subject to paragraph (a)(22)(i) of this section.\n(11) November 10, 1993, for products subject to paragraphs (a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except products that contain ferric subsulfate as covered by paragraph (d)(22) of this section and except products that contain calcium acetate monohydrate as covered by paragraph (d)(39) of this section) through (a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), (a)(23)(i), (a)(24)(i), and (a)(25) of this section.\n(12) March 2, 1994, for products subject to paragraph (a)(22)(iii) of this section.\n(13) August 5, 1991, for products subject to paragraph (a)(26) of this section, except for those that contain live yeast cell derivative and a combination of hydrocortisone and pramoxine hydrochloride.\n(14) September 2, 1994, for products subject to paragraph (a)(26)(vii) and (a)(26)(x) of this section that contain live yeast cell derivative.\n(15) September 23, 1994, for products subject to paragraph (a)(22)(iv) of this section.\n(16) June 14, 1994, for products subject to paragraph (a)(25)(ii) of this section.\n(17) April 19, 2004, for products subject to paragraph (a)(3)(ii) of this section. April 18, 2005, for products with annual sales less than $25,000.\n(18) August 15, 1995, for products subject to paragraph (a)(15)(ii) of this section.\n(19) October 2, 1987, for products subject to paragraph (a)(6)(iv)(A) of this section.\n(20) January 29, 1996, for products subject to paragraph (a)(6)(iv)(B) of this section.\n(21) April 21, 1994, for products subject to paragraph (a)(8)(iii) of this section.\n(22) April 21, 1993, for products subject to paragraph (a)(18)(ii) of this section that contain ferric subsulfate.\n(23) August 23, 1995, for products subject to paragraph (a)(6)(ii)(B) of this section.\n(24) October 7, 1996, for products subject to paragraph (a)(2)(ii) of this section.\n(25) June 19, 1996, for products subject to paragraph (a)(6)(iv)(C) of this section.\n(26) February 22, 1999, for products subject to paragraphs (a)(23)(ii) and (a)(24)(ii) of this section.\n(27) [Reserved]\n(28) October 22, 1998, for products subject to paragraphs (a)(27) and (a)(28)(i) of this section.\n(29) January 29, 1999, for products subject to paragraph (a)(12)(iv)(B) of this section.\n(30) November 5, 2002, for products subject to paragraph (a)(12)(iv)(C) of this section.\n(31) December 31, 2002, for products subject to paragraph (a)(29)(i) of this section.\n(32) June 4, 2004, for products subject to paragraphs (a)(18)(i)(B), (a)(18)(v)(B), and (a)(18)(vi)(B) of this section. June 6, 2005, for products with annual sales less than $25,000.\n(33) October 29, 2001, for products subject to paragraph (a)(6)(iv)(D) of this section.\n(34) December 9, 2004, for products subject to paragraph (a)(4)(ii) of this section. June 9, 2005, for products with annual sales less than $25,000.\n(35) [Reserved]\n(36) November 5, 2002, for products subject to paragraph (a)(28)(ii) of this section.\n(37) September 25, 2003, for products subject to paragraph (a)(26)(xi) of this section.\n(38) October 1, 2007, for products subject to paragraph (a)(12)(i)(B) of this section.\n(39) September 6, 2010, for products subject to paragraph (a)(18)(ii) of this section that contain calcium acetate monohydrate, except as provided in § 347.20(b) of this chapter.\n(40) December 17, 2012, for products subject to paragraph (a)(29)(ii) of this section. December 17, 2013, for products with annual sales less than $25,000.\n(41) September 6, 2017, for products subject to paragraph (a)(27)(iii) or (iv) of this section.\n(42) December 20, 2018, for products subject to paragraphs (a)(27)(vi) through (x) of this section.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 310—NEW DRUGS","Subpart E—Requirements for Specific New Drugs or Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"7e8661ea6feab210fd70406748153ba933cc5b902a4948520ce1ae060e6bdc4a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-310.544","next":"us/21-cfr-310.546"},"notice":"GroundRules: Original legal text. Not legal advice."}