GroundRules
21 CFR 341.20: Nasal decongestant active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—Active Ingredients
The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient:
(a) Oral nasal decongestants. (1) Phenylephrine hydrochloride.
(2) Pseudoephedrine hydrochloride.
(3) Pseudoephedrine sulfate.
(4) Phenylephrine bitartrate in an effervescent dosage form.
(b) Topical nasal decongestants. (1) Levmetamfetamine.
(2) Ephedrine.
(3) Ephedrine hydrochloride.
(4) Ephedrine sulfate.
(5) [Reserved]
(6) Naphazoline hydrochloride.
(7) Oxymetazoline hydrochloride.
(8) Phenylephrine hydrochloride.
(9) Propylhexedrine.
(10) Xylometazoline hydrochloride.
Collected 2026-08-27T02:24:47Z. Source file · JSON