eCFR Reference Browser

---

title: "21 CFR §338.10"

source: "https://www.ecfr.gov/current/title-21/section-338.10"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "338"

part_subject: "NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"

subpart_code: "B"

subpart_subject: "Active Ingredients"

section_number: "338.10"

section_subject: "Nighttime sleep-aid active ingredients."

cfr_reference: "21 CFR 338.10"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§338.10 - Nighttime sleep-aid active ingredients.