Regulatory PathRegulatory requirements compared

Active substances

Acetylsalicylic acid + Methocarbamol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ROBAXISAL325MG;400MGtablet · oralROBINS AHDiscontinued15 Apr 1960
METHOCARBAMOL AND ASPIRIN325MG;400MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued22 Dec 1982
METHOCARBAMOL AND ASPIRIN325MG;400MGtablet · oralMCNEILDiscontinued12 Feb 1986
METHOCARBAMOL AND ASPIRIN325MG;400MGtablet · oralPAR PHARMDiscontinued4 Nov 1988
METHOCARBAMOL AND ASPIRIN325MG;400MGtablet · oralSTEVENS JDiscontinued31 Jan 1995

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
EXTRA STRENGTH MUSCLE & BACK PAIN ASA 500 MG METHOCARBAMOL 400 MG & ACETYLSALICYLIC ACID 500 MG02252228500 MG; 400 MGTABLET · ORALVITA HEALTH PRODUCTS INC
EXTRA STRENGTH MUSCLE & BACK PAIN RELIEF WITH ASA02426625500 MG; 400 MGTABLET · ORALVITA HEALTH PRODUCTS INC
ROBAXISAL EXTRA STRENGTH02230949400 MG; 500 MGTABLET · ORALHALEON 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.