Regulatory PathRegulatory requirements compared

Active substance

Docosanol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ABREVA10%cream · topicalHALEON US HOLDINGSOver-the-counter25 Jul 2000
DOCOSANOL10%cream · topicalP AND LOver-the-counter19 Nov 2018
DOCOSANOL10%cream · topicalALEMBICOver-the-counter3 May 2022
DOCOSANOL10%cream · topicalP AND L DEVELOPMENTOver-the-counter7 Oct 2022
DOCOSANOL10%cream · topicalSUN PHARMA CANADAOver-the-counter26 Oct 2023
DOCOSANOL10%cream · topicalAUROBINDO PHARMA LTDOver-the-counter1 Mar 2024
DOCOSANOL10%cream · topicalDR REDDYSOver-the-counter3 Oct 2025
DOCOSANOL10%cream · topicalDR REDDYSOver-the-counter23 Oct 2025
DOCOSANOL10%cream · topicalKLM LABS PVTOver-the-counter31 Jul 2026

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
BLISTEX COLD SORE CREAMPL 53512/0002BLISTEX LIMITEDGSL
DOCOSANOL 10% CREAMPL 52731/0003DENDRON BRANDS LIMITEDP

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDOCOSANOL 10% CREAM$5.79261per GM23 Sep 2026
US NADACFT DOCOSANOL 10% CREAM$5.79261per GM23 Sep 2026
US NADACGNP DOCOSANOL 10% CREAM$5.79261per GM23 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.

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.