Is Doxylamine approved by the US FDA?

Drugs@FDA lists 8 application product lines for Doxylamine, including UNISOM (Over-the-counter); DOXYLAMINE SUCCINATE (Over-the-counter); DOXYLAMINE SUCCINATE (Over-the-counter); DECAPRYN (Discontinued); DOXYLAMINE SUCCINATE (Discontinued).

Are there safety signals or safety updates for Doxylamine?

US FDA: 3 entries (latest 2022-12-01).

Active substance

Doxylamine

US FDA 8
Safety 3

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
UNISOM	25MG	tablet · oral	CHATTEM	Over-the-counter	18 Oct 1978
DOXYLAMINE SUCCINATE	25MG	tablet · oral	PERRIGO	Over-the-counter	18 Sep 1996
DOXYLAMINE SUCCINATE	25MG	tablet · oral	LNK	Over-the-counter	27 Aug 2004
DECAPRYN	25MG; 12.5MG	tablet · oral	SANOFI AVENTIS US	Discontinued	7 Apr 1948
DOXYLAMINE SUCCINATE	25MG	tablet · oral	COPLEY PHARM	Discontinued	8 Oct 1985
DOXY-SLEEP-AID	25MG	tablet · oral	PAR PHARM	Discontinued
DOXYLAMINE SUCCINATE	25MG	tablet · oral	QUANTUM PHARMICS	Discontinued
UNISOM	25MG	capsule · oral	PFIZER	Discontinued

Safety signals and safety-related labeling changes

US FDA 1 Dec 2022 UNISOM — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 18 Jun 2018 BONJESTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2018 DICLEGIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for doxylamine →

Combinations containing Doxylamine

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.