21 CFR § 1308.22
Excluded substances
June 25, 2020
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
Open Table
| 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 |
[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 44283, Aug. 28, 2009; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, Feb. 8, 2016]
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