Regulatory PathRegulatory requirements compared

Active substances

Acetylsalicylic acid + Caffeine + Paracetamol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGtablet · oralHALEON US HOLDINGSOver-the-counter14 Jan 1998
ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGtablet · oralPERRIGOOver-the-counter26 Nov 2001
ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGtablet · oralGRANULESOver-the-counter23 Feb 2021
ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGtablet · oralAUROBINDO PHARMA LTDOver-the-counter2 Feb 2022

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
ALKA-SELTZER XSPL 00010/0510BAYER PLCGSL
ANADIN EXTRAPL 44673/0199HALEON UK TRADING LIMITEDGSL
ANADIN EXTRA 300MG/200MG/45MG TABLETSPL 44673/0248HALEON UK TRADING LIMITEDP
ANADIN EXTRA SOLUBLE TABLETSPL 44673/0200HALEON UK TRADING LIMITEDGSL
EXTRA POWER PAIN CONTROL CAPLETSPL 29831/0164WOCKHARDT UK LIMITEDGSL
EXTRA POWER PAIN CONTROL CAPLETS (P)PL 29831/0165WOCKHARDT UK LIMITEDP
MORRISONS PAIN CONTROL EXTRA TABLETSPL 29831/0164WOCKHARDT UK LIMITEDGSL
PANMIGROL MIGRAINE AND HEADACHE RELIEF 250 MG /250 MG /65 MG FILM COATED TABLETSPL 44673/0229HALEON UK TRADING LIMITEDGSL
PANMIGROL MIGRAINE PAIN RELIEF 250 MG /250 MG /65 MG FILM COATED TABLETSPL 44673/0231HALEON UK TRADING LIMITEDP
SUPERDRUG EXTRA POWER PAIN CONTROL TABLETSPL 29831/0164WOCKHARDT UK LIMITEDGSL
TESCO EXTRA POWER PAIN CONTROL TABLETSPL 29831/0164WOCKHARDT UK LIMITEDGSL
WELL PHARMACEUTICALS PAIN CONTROL EXTRA TABLETSPL 29831/0164WOCKHARDT UK LIMITEDGSL
WOCKHARDT DUAL ACTION PAIN CONTROL TABLETSPL 29831/0164WOCKHARDT UK LIMITEDGSL

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACASPIRIN-ACETAMINOPHEN-CAFFEINE TABLET$0.06482per EA23 Sep 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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.