Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter D - DRUGS FOR HUMAN USEPart 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B - ACTIVE INGREDIENTS
Section 338.10 - Nighttime sleep-aid active ingredients

21 C.F.R. § 338.10

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Current through September 30, 2024
Section 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.

21 C.F.R. §338.10