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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 Oct 01, 2021.

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

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[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR338]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE
 
PART 338NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

Subpart B - Active Ingredients

Sec. 338.10 Nighttime sleep-aid active ingredients.

The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in § 338.50(d):

(a) Diphenhydramine hydrochloride.

(b) Diphenhydramine citrate.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 54 FR 6826, Feb. 14, 1989, unless otherwise noted.

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