Regulatory PathRegulatory requirements compared

Active substances

Acrivastine + Pseudoephedrine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SEMPREX-D8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralENDO OPERATIONSDiscontinued25 Mar 1994

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
BENADRYL ALLERGY RELIEF PLUS DECONGESTANT CAPSULESPL 15513/0017MCNEIL PRODUCTS LIMITEDP

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffPseudoephedrine 60mg / Acrivastine 8mg capsules£4.1012 capsule1 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), 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.