Regulatory PathRegulatory requirements compared

Active substances

Betamethasone + Clotrimazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OPIZOLE-B CREAM1,0.05 % (W/W),% (W/W)Cream · Topical1 TubeSAR 11.00Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
LOTRIDERM CREAM0.05, 1 %Cream · Topical1 TubeSAR 7.40NCE · PrescriptionSCHERING-PLOUGHWithdrawn by MAH · Not Marketed
LOTRIDERM CREAM0.05, 1 %Cream · Topical1 TubeSAR 14.80NCE · PrescriptionOrganon BelgiumWithdrawn by MAH · Not Marketed
LOTRIDERM CREAM0.05, 1 %Cream · Topical1 TubeSAR 21.90NCE · PrescriptionSCHERING-PLOUGHWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

FUNGAL INFECTIONS OF THE GENITAL TRACT - CANDIDIASIS OF VULVA AND VAGINA & CANDIDIASIS OF OTHER UROGENITAL SITES

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

ProductStrengthForm · routeApplicantStatusFirst approved
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%cream · topicalTAROPrescription29 May 2001
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%cream · topicalFOUGERA PHARMSPrescription5 Jun 2001
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%cream · topicalACTAVIS MID ATLANTICPrescription2 Aug 2002
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%lotion · topicalSUN PHARMA CANADAPrescription28 Jul 2004
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%lotion · topicalFOUGERA PHARMSPrescription16 Jun 2005
LOTRISONEEQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**cream · topicalORGANONDiscontinued10 Jul 1984
LOTRISONEEQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**lotion · topicalMERCK SHARP DOHMEDiscontinued8 Dec 2000
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEEQ 0.05% BASE;1%cream · topicalGLENMARK SPECLTDiscontinued30 Oct 2015

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LOTRIDERM006111740.05 %; 1 %CREAM · TOPICALORGANON CANADA INC.
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE024964101 % / W/W; 0.05 % / W/WCREAM · TOPICALTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffBetamethasone dipropionate 0.064% / Clotrimazole 1% cream£6.3430 gram1 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), 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.