Regulatory PathRegulatory requirements compared

Active substance

Tioconazole

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
VAGISTAT-16.5%ointment · vaginalCOMBEOver-the-counter11 Feb 1997
TIOCONAZOLE6.5%ointment · vaginalPERRIGOOver-the-counter21 Nov 2001
TZ-31%cream · topicalPFIZERDiscontinued18 Feb 1983

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
TIOCONAZOLE 283 MG/ML MEDICATED NAIL LACQUERPL 17780/1001ZENTIVA PHARMA UK LIMITEDPOM
TROSYL NAIL SOLUTIONPL 00057/0236PFIZER LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFT TIOCONAZOLE-1 6.5% OINTMENT$2.40894per GM23 Sep 2026
US NADACTIOCONAZOLE 1 6.5% OINTMENT$2.40894per GM23 Sep 2026
US NADACTIOCONAZOLE-1 6.5% OINTMENT$2.40894per GM23 Sep 2026
NHS Drug TariffTioconazole 283mg/ml medicated nail lacquer£36.5112 ml1 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.

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.