21 CFR 1308.22 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 1300.01 To Parts 1403-1499) — Drug Enforcement Administration, Department Of Justice (§ 1300.01 To Parts 1322-1399) — Schedules Of Controlled Substances (§ 1308.01 To § 1308.49) — Excluded Nonnarcotic Substances (§ 1308.21 And § 1308.22) — Excluded substances.

4 Aug 2016

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
21 CFR 1308.22
[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]