21 CFR 1308.22: Excluded substances.

The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):

Excluded Nonnarcotic Products

Company Trade name NDC code Form Controlled substance (mg or mg/ml)

Aphena Pharma Solutions—New York, LLC Nasal Decongestant Inhaler/Vapor Inhaler IN Levmetamfetamine (l-Desoxyephedrine) 50.00

Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00

Goldline Laboratories Guiaphed Elixir 00182-1377 EL Phenobarbital 4.00

Goldline Laboratories Tedrigen Tablets 00182-0134 TB Phenobarbital 8.00

Hawthorne Products Inc Choate's Leg Freeze LQ Chloral hydrate 246.67

Parke-Davis & Co Tedral 00071-0230 TB Phenobarbital 8.00

Parke-Davis & Co Tedral Elixir 00071-0242 EX Phenobarbital 40.00

Parke-Davis & Co Tedral S.A. 00071-0231 TB Phenobarbital 8.00

Parke-Davis & Co Tedral Suspension 00071-0237 SU Phenobarbital 80.00

Parmed Pharmacy Asma-Ese 00349-2018 TB Phenobarbital 8.10

Procter & Gamble Co., The Vicks VapoInhaler 37000-686-01 IN Levmetamfetamine (l-Desoxyephedrine) 50.00

Rondex Labs Azma-Aids 00367-3153 TB Phenobarbital 8.00

Smith Kline Consumer Benzedrex 49692-0928 IN Propylhexedrine 250.00

Sterling Drug, Inc Bronkolixir 00057-1004 EL Phenobarbital 0.80

Sterling Drug, Inc Bronkotabs 00057-1005 TB Phenobarbital 8.00

White Hall Labs Primatene (P-tablets) 00573-2940 TB Phenobarbital 8.00