21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart B [§ 338.10 - § 338.10]

§ 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.

cite as: 21 CFR 338.10