21 C.F.R. § 1308.22 : Food and Drugs — DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE — SCHEDULES OF CONTROLLED SUBSTANCES —EXCLUDED NONNARCOTIC SUBSTANCES — 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

21 C.F.R. §1308.22

38 FR 8255, 3/30/1973. Redesignated at 38 FR 26609, 9/24/1973, and amended at 41 FR 16553, 4/20/1976; 41 FR 53477, 12/7/1976; 46 FR 51603, 10/21/1981; 47 FR 45867, 10/14/1982; 54 FR 2100, 1/19/1989; 55 FR 12162, 3/30/1990; 62 FR 13968, 3/24/1997; 74 FR 44283, 8/28/2009; 80 FR 65634, 65637, 10/27/2015; 81 FR 6453, 2/8/2016