Is Ibuprofen + Paracetamol approved by the US FDA?

Drugs@FDA lists 13 application product lines for Ibuprofen + Paracetamol, including ADVIL DUAL ACTION WITH ACETAMINOPHEN (Over-the-counter); ACETAMINOPHEN AND IBUPROFEN (Over-the-counter); COMBOGESIC (Prescription); ACETAMINOPHEN AND IBUPROFEN (Over-the-counter); ACETAMINOPHEN AND IBUPROFEN (Over-the-counter).

Active substances

Ibuprofen + Paracetamol

US FDA 13
Health Canada 4
US price lines 1
NHS prices 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	tablet · oral	HALEON US HOLDINGS	Over-the-counter	28 Feb 2020
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	L PERRIGO CO	Over-the-counter	28 Feb 2023
COMBOGESIC	325MG;97.5MG	tablet · oral	AFT PHARMS US	Prescription	1 Mar 2023
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	PHARMAZONE	Over-the-counter	10 Jul 2023
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	GRANULES	Over-the-counter	13 Jul 2023
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	BIONPHARMA	Over-the-counter	1 Aug 2023
COMBOGESIC IV	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	solution · intravenous	HIKMA PHARMS	Prescription	17 Oct 2023
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	AUROBINDO PHARMA LTD	Over-the-counter	26 Mar 2024
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	GLENMARK PHARMS LTD	Over-the-counter	26 Apr 2024
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	DR REDDYS	Over-the-counter	23 Aug 2024
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	LNK INTL INC	Over-the-counter	11 Dec 2025
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	TARO	Over-the-counter	2 Jan 2026
ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	tablet · oral	STRIDES PHARMA	Discontinued	17 Jan 2025

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADVIL PLUS ACETAMINOPHEN	02519267	125 MG; 250 MG	TABLET · ORAL	HALEON CANADA ULC
COMBOGESIC	02488280	97.5 MG; 325 MG	TABLET · ORAL	AFT PHARMACEUTICALS (CAN) LIMITED
COMBOGESIC IV	02544806	10 MG / ML; 3 MG / ML	SOLUTION · INTRAVENOUS	AFT PHARMACEUTICALS (CAN) LIMITED
TYLENOL DUAL ACTION ACETAMINOPHEN + IBUPROFEN	02558572	125 MG; 250 MG	TABLET · ORAL	KENVUE CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GNP ACETAMINOPHEN-IBUPROFEN 250-125 MG TABLET	$0.10711	per EA	23 Sep 2026
NHS Drug Tariff	Paracetamol 500mg / Ibuprofen 200mg tablets	£3.17	12 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

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.