Regulatory PathRegulatory requirements compared

Active substance

Clotrimazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CANESTEN CREAM 1%1 %Cream · Topical1 TubeSAR 16.15NCE · OTCBAYER CONSUMER CARE AGValid
CANESTEN SOLUTION 1%1 %Cutaneous solution · Topical1 Dropper ContainerSAR 16.15NCE · OTCBAYER CONSUMER CARE AGValid
CANESTEN VAGINAL TAB 100MG100 mgVaginal tablet · Vaginal use6 BlisterSAR 21.70NCE · OTCBAYER CONSUMER CARE AGValid
CANESTEN-1 VAG. CREAM 10%10 %Vaginal cream · Vaginal use1 TubeSAR 29.20NCE · OTCBAYER CONSUMER CARE AGValid
CANESTEN-1 VAG.TAB 500MG WITH APPLICATOR500 mgVaginal tablet · Vaginal use1 BlisterSAR 21.70NCE · OTCBAYER CONSUMER CARE AGValid
CLOTREX1 %Oral drops · Auricular use1 Dropper ContainerSAR 10.80Generic · OTCHAYAT PHARMACEUTICAL INDUSTRIESValid
CLOTRIM 100 MG VAGINAL TABLETS100 mgTablet · Vaginal use6 BlisterSAR 14.90Generic · OTCJORDAN RIVER PHARMACEUTICAL INDUSTRIESValid
CLOTRIZOLE 100MG VAGINAL TABLETS100 mgTablet · Vaginal use6 BlisterSAR 12.55Generic · OTCBATTERJEE PHARMACETICAL FACTORYValid
DERMATIN CREAM 1%1 %Cream · Topical1 TubeSAR 10.00Generic · OTCPHARCO PHARMACEUTICALValid
DERMATIN SOLUTION 1%1 %Solution · Topical1 BottleSAR 14.50Generic · OTCPHARCO PHARMACEUTICALValid
FUNGO 1% CREAM1 gCream · Topical1 TubeSAR 7.05Generic · OTCBATTERJEE PHARMACETICAL FACTORYValid
OPIZOLE 1% CREAM1 %Cream · Topical1 TubeSAR 5.90Generic · OTCOMAN PHARMACEUTICAL PRODUCTSValid
OTOZOL 1% EAR DROP1 %Ear drops · Auricular use1 Dropper ContainerSAR 8.30Generic · OTCAmman Pharmaceutical Industries (API)Valid
CANESTEN CREAM 1%1 %Cream · Topical1 TubeSAR 16.15NCE · PrescriptionBAYER PHARMA AGWithdrawn by MAH · Not Marketed
CANESTEN SOLUTION 1%1 %Solution · Topical1 Dropper ContainerSAR 16.15NCE · OTCBAYER PHARMA AGWithdrawn by MAH · Not Marketed
CANESTEN VAGINAL TAB 100MG100 mgTablet · Vaginal use6 BlisterSAR 17.95NCE · OTCBAYER PHARMA AGWithdrawn by MAH · Not Marketed
CANESTEN-1 VAG. CREAM 10%10 %Vaginal cream · Vaginal use1 TubeSAR 29.20NCE · OTCBAYER PHARMA AGWithdrawn by MAH · Not Marketed
CANESTEN-1 VAG.TAB 500MG WITH APPLICATOR500 mgTablet · Vaginal use1 BlisterSAR 17.95NCE · OTCBAYER PHARMA AGWithdrawn by MAH · Not Marketed
CLOZOLE 0.1% TOPICAL CREAM1 %Cream · Topical1 TubeSAR 11.90Generic · OTCTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
CLOZOLE 1% TOPICAL SOLUTION1 %Cutaneous liquid · Topical1 BottleSAR 13.50Generic · OTCTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
CLOZOLE VAGINAL CREAM10 %Cream · Vaginal use1 TubeSAR 22.85Generic · OTCTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
DERMATIN 1% POWDER1 %Powder · Topical1 BottleSAR 5.15Generic · OTCPHARCO PHARMACEUTICALWithdrawn by MAH · Not Marketed
MEDSTEN 1% CREAM1 %Cream · Topical1 TubeSAR 11.75Generic · OTCMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESWithdrawn by MAH · Not Marketed
MICOTER 1% SOLUTION1 %Oral solution · Oral use1 BottleSAR 10.75Generic · OTCALCON CUSIWithdrawn by MAH · Not Marketed
MICOTER CREAM 1%1 %Cream · Topical1 TubeSAR 11.10Generic · OTCALCON CUSIWithdrawn by MAH · Not Marketed

1 more — full table

Indications — CHI Daman Drug Formulary

FUNGAL INFECTIONS OF THE GENITAL TRACT - CANDIDIASIS OF OTHER UROGENITAL SITES; MATERNAL AND CHILD HEALTHCARE- VAGINAL CANDIDIASIS IN PREGNANCY; RENAL TRANSPLANT; TINEA CORPORIS, TINEA CRURIS, AND TINEA PEDIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
MYCELEX1%solution · topicalBAYER HLTHCAREOver-the-counter15 Jan 1979
LOTRIMIN AF1%cream · topicalSCHERING PLOUGHOver-the-counter27 Oct 1989
LOTRIMIN AF1%lotion · topicalSCHERING PLOUGHOver-the-counter27 Oct 1989
LOTRIMIN AF1%solution · topicalSCHERING PLOUGHOver-the-counter27 Oct 1989
CLOTRIMAZOLE1%cream · vaginalENCUBEOver-the-counter16 Jul 1993
CLOTRIMAZOLE1%cream · topicalSUN PHARMA CANADAPrescription31 Aug 1993
CLOTRIMAZOLE1%solution · topicalTEVAPrescription28 Feb 1995
CLOTRIMAZOLE1%cream · vaginalSUN PHARMA CANADAOver-the-counter4 Dec 1995
CLOTRIMAZOLE1%solution · topicalSUN PHARMA CANADAPrescription29 Jul 1996
TRIVAGIZOLE 32%cream · vaginalSUN PHARMA CANADAOver-the-counter12 Apr 2000
CLOTRIMAZOLE10MGtroche/lozenge · oralHIKMA PHARMSPrescription29 Jul 2004
CLOTRIMAZOLE10MGtroche/lozenge · oralPADAGIS USPrescription28 Oct 2005
CLOTRIMAZOLE1%cream · topicalFOUGERA PHARMSPrescription2 Sep 2008
CLOTRIMAZOLE1%cream · topicalGLENMARK PHARMSPrescription3 Aug 2010
CLOTRIMAZOLE1%solution · topicalNOVITIUM PHARMAPrescription15 Feb 2019
CLOTRIMAZOLE1%solution · topicalTP ANDA HOLDINGSPrescription25 Jul 2019
CLOTRIMAZOLE1%solution · topicalSCIEGEN PHARMSPrescription16 Oct 2023
CLOTRIMAZOLE10MGtroche/lozenge · oralTHINQ PHARM-CRO PVTPrescription29 Feb 2024
CLOTIC1%solution/drops · oticCARWIN PHARM ASSOCPrescription26 Sep 2025
LOTRIMIN1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · topicalSCHERING PLOUGHDiscontinued3 Feb 1975
LOTRIMIN1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**cream · topicalSCHERING PLOUGHDiscontinued18 Mar 1975
GYNE-LOTRIMIN100MGtablet · vaginalBAYER HEALTHCARE LLCDiscontinued24 Mar 1976
GYNE-LOTRIMIN1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**cream · vaginalBAYER HEALTHCARE LLCDiscontinued8 Nov 1978
MYCELEX1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · topicalBAYER HLTHCAREDiscontinued15 Jan 1979
MYCELEX1%cream · topicalBAYER HEALTHCARE LLCDiscontinued15 Jan 1979

11 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CANESTEN 1 DAY INTERNAL CREAM0215088310 % / W/WCREAM · VAGINALBAYER INC
CANESTEN 1% TOPICAL CREAM021508671 % / %CREAM · TOPICALBAYER INC
CANESTEN 3 DAY INTERNAL CREAM021509052 % / W/WCREAM · VAGINALBAYER INC
CANESTEN 6 DAY INTERNAL CREAM021508911 % / W/WCREAM · VAGINALBAYER INC
CANESTEN COMBI 1 DAY022641021 % / W/W; 500 MG / VTABCREAM; VAGINAL TABLET; KIT · VAGINAL; TOPICALBAYER INC
CANESTEN COMBI 1 DAY INTERNAL + EXTERNAL CREAMS0223050910 % / W/W; 1 % / W/WKIT; CREAM · TOPICAL; VAGINALBAYER INC
CANESTEN COMBI 1 DAY SOFT CAPSULE + EXTRA STRENGTH EXTERNAL CREAM02547260500 MG / CAP; 2 % / W/WCREAM; KIT; VAGINAL CAPSULE · VAGINAL; TOPICALBAYER INC
CANESTEN COMBI 3 DAY022640991 % / W/W; 200 MG / VTABVAGINAL TABLET; KIT; CREAM · VAGINAL; TOPICALBAYER INC
CANESTEN COMFORTAB 102150859500 MGVAGINAL TABLET · VAGINALBAYER INC
CANESTEN COMFORTAB 302150840200 MGVAGINAL TABLET · VAGINALBAYER INC
CANESTEN EXTERNAL ANTIFUNGAL CREAM022394321 % / W/WCREAM · TOPICALBAYER INC
CANESTEN EXTERNAL CREAM023117201 %CREAM · VAGINAL; TOPICALBAYER INC
CANESTEN EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM024909272 % / W/WCREAM · TOPICALBAYER INC
CANESTEN SOFT CAPSULE 102547252500 MGVAGINAL CAPSULE · VAGINALBAYER INC
CLOTRIMADERM TOPICAL008123821 %CREAM · TOPICALTARO PHARMACEUTICALS INC
CLOTRIMADERM VAGINAL 3008123742 % / W/WCREAM · VAGINALTARO PHARMACEUTICALS INC
CLOTRIMADERM VAGINAL 6008123661 % / W/WCREAM · VAGINALTARO PHARMACEUTICALS INC
CLOTRIMAZOLE EXTERNAL ANTIFUNGAL CREAM024623971 % / W/WCREAM · TOPICALTARO PHARMACEUTICALS INC
CLOTRIMAZOLE EXTRA STRENGTH EXTERNAL ANTIFUNGAL CREAM025033602 % / W/WCREAM · VAGINALTARO PHARMACEUTICALS INC
CLOTRIMAZOLE TOPICAL022293801 %CREAM · TOPICALTARO PHARMACEUTICALS INC
CLOTRIMAZOLE VAGINAL 3022293792 %CREAM · VAGINALTARO PHARMACEUTICALS INC
CLOTRIMAZOLE VAGINAL 6022293781 %CREAM · VAGINALTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLOTRIMAZOLE 1% SOLUTION$2.01789per ML23 Sep 2026
US NADACCLOTRIMAZOLE 1% SOLUTION$2.742per ML23 Sep 2026
US NADACCLOTRIMAZOLE 1% SOLUTION$0.42569per ML23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.08208per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.04735per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.06293per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.11771per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.19892per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.13296per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.16222per GM23 Sep 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.34307per GM22 Apr 2026
US NADACCLOTRIMAZOLE 1% TOPICAL CREAM$0.21853per GM23 Sep 2026
NHS Drug TariffClotrimazole 1% cream£1.5220 gram1 Oct 2026
NHS Drug TariffClotrimazole 1% cream£3.8050 gram1 Oct 2026
NHS Drug TariffClotrimazole 1% solution£2.5420 ml1 Oct 2026
NHS Drug TariffClotrimazole 1% spray£5.0040 ml1 Oct 2026
NHS Drug TariffClotrimazole 10% cream and Clotrimazole 2% cream£11.961 pack1 Oct 2026
NHS Drug TariffClotrimazole 10% vaginal cream£8.365 gram1 Oct 2026
NHS Drug TariffClotrimazole 100mg pessaries£3.856 pessary1 Oct 2026
NHS Drug TariffClotrimazole 2% cream£6.4120 gram1 Oct 2026
NHS Drug TariffClotrimazole 200mg pessaries£3.413 pessary1 Oct 2026
NHS Drug TariffClotrimazole 500mg pessaries£8.541 pessary1 Oct 2026
NHS Drug TariffClotrimazole 500mg pessary and Clotrimazole 2% cream£5.731 pack1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.3. Antifungal medicines · core
    Vulvovaginal candidosis
    Local > Topical > Other: 1% vaginal cream; 10% vaginal cream; 100 mg vaginal tablet; 500 mg vaginal tablet

Safety signals and safety-related labeling changes

All safety entries for clotrimazole →

Combinations containing Clotrimazole

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.