Regulatory PathRegulatory requirements compared

Active substances

Acetylsalicylic acid + Butalbital + Caffeine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LANORINAL325MG;50MG;40MGcapsule · oralSANDOZPrescription28 Dec 1981
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGcapsule · oralMPP PHARMAPrescription13 Jun 2007
FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralALLERGANDiscontinued4 May 1976
FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralALLERGANDiscontinued4 May 1976
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralWATSON LABSDiscontinued21 Feb 1979
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralHIKMA INTL PHARMSDiscontinued5 Jun 1979
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralACTAVIS ELIZABETHDiscontinued25 Jul 1979
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralPURACAP PHARMDiscontinued30 Apr 1980
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralFOSUN PHARMADiscontinued30 Jul 1980
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGcapsule · oralWATSON LABSDiscontinued16 Jun 1982
LANORINAL325MG;50MG;40MGtablet · oralLANNETTDiscontinued1 Jul 1982
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralSTRIDES PHARMADiscontinued22 Sep 2016
BUTALBITAL, ASPIRIN AND CAFFEINE500MG;50MG;40MGcapsule · oralLGM PHARMADiscontinued18 Oct 2021
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralIVAX PHARMSDiscontinued
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralQUANTUM PHARMICSDiscontinued
BUTALBITAL, ASPIRIN AND CAFFEINE325MG;50MG;40MGtablet · oralHALSEYDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE0255469040 MG; 50 MG; 330 MGCAPSULE · ORALAPOTEX INC
FIORINAL0022632750 MG; 330 MG; 40 MGCAPSULE · ORALARALEZ PHARMACEUTICALS CANADA INC
TEVA-TECNAL0060821140 MG; 330 MG; 50 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-TECNAL0060823850 MG; 40 MG; 330 MGCAPSULE · ORALTEVA CANADA LIMITED
TRIANAL TABLET0197140940 MG; 50 MG; 330 MGTABLET · ORALLABORATOIRE RIVA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBUTALBITAL-ASPIRIN-CAFFEINE 50-325-40 MG CAPSULE$0.94823per 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), 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.