21 C.F.R. § 1308.22
Excluded substances.
Published Feb 8, 201681 FR 6453
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)):
| 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]