21 CFR 1308.22 – Excluded substances
Current as of: 2024 | Check for updates
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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 ( | 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 |