Is Diphenhydramine + Ibuprofen approved by the US FDA?

Drugs@FDA lists 9 application product lines for Diphenhydramine + Ibuprofen, including ADVIL PM (Over-the-counter); ADVIL PM (Over-the-counter); IBUPROFEN AND DIPHENHYDRAMINE CITRATE (Over-the-counter); IBUPROFEN AND DIPHENHYDRAMINE CITRATE (Over-the-counter); IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE (Over-the-counter).

Active substances

Diphenhydramine + Ibuprofen

US FDA 9
Health Canada 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ADVIL PM	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	capsule · oral	HALEON US HOLDINGS	Over-the-counter	21 Dec 2005
ADVIL PM	38MG;200MG	tablet · oral	HALEON US HOLDINGS	Over-the-counter	21 Dec 2005
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	tablet · oral	PERRIGO R AND D	Over-the-counter	22 Dec 2008
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	8 Jul 2009
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	capsule · oral	BIONPHARMA	Over-the-counter	22 Nov 2010
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	capsule · oral	ONESOURCE	Over-the-counter	5 Mar 2012
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	capsule · oral	AUROBINDO PHARMA LTD	Over-the-counter	14 Feb 2019
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	tablet · oral	AUROBINDO PHARMA	Over-the-counter	31 May 2022
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	tablet · oral	PLD ACQUISITIONS LLC	Over-the-counter	11 Apr 2024

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADVIL FLU	02401193	25 MG; 200 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL NIGHTTIME	02355841	200 MG; 25 MG	CAPSULE · ORAL	HALEON CANADA ULC

Components

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.