Regulatory PathRegulatory requirements compared

Active substances

Calcium carbonate + Famotidine + Magnesium hydroxide

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PEPCID COMPLETE800MG;10MG;165MGtablet, chewable · oralKENVUE BRANDSOver-the-counter16 Oct 2000
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGtablet, chewable · oralPERRIGO R AND DOver-the-counter6 Feb 2008
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGtablet, chewable · oralPERRIGO R AND DDiscontinued29 Aug 2016

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PEPCID COMPLETE02243053800 MG; 165 MG; 10 MGTABLET (CHEWABLE) · ORALKENVUE CANADA INC.

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.