21 C.F.R. § 338.10
Nighttime sleep-aid active ingredients.
Cite as 21 C.F.R. § 338.10 (2026)
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.
- Cross-references to the CFR
- 338.50