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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 9]
[CITE: 21CFR1308.22]



TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE

PART 1308 -- SCHEDULES OF CONTROLLED SUBSTANCES

Excluded Nonnarcotic Substances

Sec. 1308.22 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, LLCNasal Decongestant Inhaler/Vapor InhalerINLevmetamfetamine (l-Desoxyephedrine)50.00
Bioline LaboratoriesTheophed00719-1945TBPhenobarbital8.00
Goldline LaboratoriesGuiaphed Elixir00182-1377ELPhenobarbital4.00
Goldline LaboratoriesTedrigen Tablets00182-0134TBPhenobarbital8.00
Hawthorne Products IncChoate's Leg FreezeLQChloral hydrate246.67
Parke-Davis & CoTedral00071-0230TBPhenobarbital8.00
Parke-Davis & CoTedral Elixir00071-0242EXPhenobarbital40.00
Parke-Davis & CoTedral S.A.00071-0231TBPhenobarbital8.00
Parke-Davis & CoTedral Suspension00071-0237SUPhenobarbital80.00
Parmed PharmacyAsma-Ese00349-2018TBPhenobarbital8.10
Procter & Gamble Co., TheVicks VapoInhaler37000-686-01INLevmetamfetamine (l-Desoxyephedrine)50.00
Rondex LabsAzma-Aids00367-3153TBPhenobarbital8.00
Smith Kline ConsumerBenzedrex49692-0928INPropylhexedrine250.00
Sterling Drug, IncBronkolixir00057-1004ELPhenobarbital0.80
Sterling Drug, IncBronkotabs00057-1005TBPhenobarbital8.00
White Hall LabsPrimatene (P-tablets)00573-2940TBPhenobarbital8.00

[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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