21 C.F.R. § 1308.22
Excluded substances.
Cite as 21 C.F.R. § 1308.22 (2026)
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
[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]
- Cross-references to the US Code
- 21:30121:811