Regulatory PathRegulatory requirements compared

Active substance

Miconazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CANDIZOLE 2% VAGINAL CREAM2 %Vaginal cream · Vaginal use1 TubeSAR 17.65Generic · OTCMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESValid
CONAZOL 2% CREAM2 %Cream · Topical1 TubeSAR 6.40Generic · OTCDEEF PHARMACEUTICAL INDUSTRIESValid
CONAZOL 2% CREAM2 %Cream · Topical1 TubeSAR 9.60Generic · OTCDEEF PHARMACEUTICAL INDUSTRIESValid
CONAZOLE VAGINAL CREAM 20MG-1GM2 %Vaginal cream · Vaginal use1 TubeSAR 14.10Generic · OTCDEEF PHARMACEUTICAL INDUSTRIESValid
CONAZOLE VAGINAL CREAM 20MG-1GM2 %Vaginal cream · Vaginal use1 TubeSAR 21.40Generic · OTCDEEF PHARMACEUTICAL INDUSTRIESValid
DAKTARIN CREAM 2%2 %Cream · Topical1 TubeSAR 15.85NCE · OTCJohnson & Johnson Consumer NV/SAValid
DAKTARIN ORAL GEL 2%2 %Oral gel · Oral use1 TubeSAR 16.50NCE · OTCJohnson & Johnson Consumer NV/SAValid
DAKTARIN POWDER 2%2 %Powder · Topical1 BottleSAR 11.35NCE · OTCJANSSEN-CILAGValid
FUNGYZOLE 2% TOPICAL CREAM2 %Cream · Topical1 TubeSAR 10.70Generic · OTCMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESValid
GYNO-CANDIZOL 200 MG VAGINAL OVULES200 mgVaginal capsule, soft · Vaginal use7 OvuleSAR 13.40Generic · OTCMS Pharma Saudi (MSPS)Valid
GYNO-CANDIZOL 400 MG VAGINAL OVULES400 mgVaginal capsule, soft · Vaginal use3 OvuleSAR 11.00Generic · OTCMS Pharma Saudi (MSPS)Valid
GYNO-DAKTARIN 1200MG VAGINAL CAPSULE1200 mgCapsule · Vaginal use1 BlisterSAR 20.70NCE · OTCJANSSEN-CILAGValid
GYNO-DAKTARIN CREAM WITH 16 APPLICATORS2 %Cream · Topical1 TubeSAR 25.20NCE · OTCJohnson & Johnson Consumer NV/SAValid
GYNO-DAKTARIN OVULES 400 MG.400 mgSuppository · Vaginal use3 BlisterSAR 23.90NCE · OTCJANSSEN-CILAGValid
GYNO-MIKOZAL 200MG VAG.OVULE200 mgPessary · Vaginal use7 BlisterSAR 21.95Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
GYNO-MIKOZAL 400MG VAG.OVULE400 mgPessary · Vaginal use3 BlisterSAR 18.25Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
GYNO-MIKOZAL CREAM 78 GM2 %Cream · Topical1 TubeSAR 23.80Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
MICONAZ 2% CREAM2 %Cream · Topical1 TubeSAR 5.75Generic · OTCMEDICAL UNION PHARMACEUTICALS COValid
MICONAZ 2% POWDER2 %Cutaneous powder · Topical1 BottleSAR 10.80Generic · OTCMEDICAL UNION PHARMACEUTICALS COValid
MIKOZAL 2% cream2 %Cream · Topical1 TubeSAR 14.10Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
MIRAGEL 2% ORAL GEL2 %Gel · Oral use1 TubeSAR 14.85Generic · OTCJamjoom Pharmaceuticals Factory CompanyValid
MYCOHEAL 2% ORAL GEL2 %Gel · Oral use1 TubeSAR 12.65NCE · OTCDAR ALDAWAValid
MYCOHEAL 400MG VAGINAL SUPPOSITORIES400 mgSuppository · Vaginal use3 BlisterSAR 12.25Generic · OTCDAR ALDAWAValid
MYCOLESS CREAM2 %Cream · Topical1 TubeSAR 5.75Generic · OTCBATTERJEE PHARMACETICAL FACTORYValid
CANDIZOL 2% CREAM2 %Cream · Topical1 TubeSAR 4.30Generic · OTCUNITED PHARMACEUTICAL CO.Withdrawn by MAH · Not Marketed

15 more — full table

Indications — CHI Daman Drug Formulary

FUNGAL INFECTIONS OF THE GENITAL TRACT - CANDIDIASIS OF VULVA AND VAGINA; HUMAN IMMUNODEFICIENCY VIRUS

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

ProductStrengthForm · routeApplicantStatusFirst approved
MONISTAT 72%cream · vaginalMEDTECH PRODUCTSOver-the-counter30 Jan 1974
MONISTAT 7100MGsuppository · vaginalMEDTECH PRODUCTSOver-the-counter15 Mar 1982
MONISTAT 3200MGsuppository · vaginalMEDTECH PRODUCTSPrescription15 Aug 1984
MONISTAT 7 COMBINATION PACK2%,100MGcream, suppository · topical, vaginalMEDTECH PRODUCTSOver-the-counter26 Apr 1993
MICONAZOLE NITRATE100MGsuppository · vaginalCOSETTE PHARMS NCOver-the-counter19 Nov 1993
MICONAZOLE NITRATE200MGsuppository · vaginalACTAVIS PHARMAPrescription19 Nov 1993
MICONAZOLE 72%cream · vaginalENCUBEOver-the-counter29 Mar 1996
MONISTAT 3 COMBINATION PACK2%,200MGcream, suppository · topical, vaginalMEDTECH PRODUCTSOver-the-counter16 Apr 1996
MICONAZOLE NITRATE2%cream · vaginalSUN PHARMA CANADAOver-the-counter13 Jan 1997
MICONAZOLE NITRATE2%cream · vaginalPERRIGOOver-the-counter15 May 1997
MONISTAT 34%cream · vaginalMEDTECH PRODUCTSOver-the-counter30 Mar 1998
M-ZOLE 3 COMBINATION PACK2%,200MGcream, suppository · topical, vaginalCOSETTE PHARMS NCOver-the-counter16 Apr 1999
MICONAZOLE NITRATE COMBINATION PACK2%,200MGcream, suppository · topical, vaginalL PERRIGO COOver-the-counter20 Apr 1999
MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%cream · topical, vaginalMEDTECH PRODUCTSOver-the-counter2 Feb 2001
MONISTAT 3 COMBINATION PACK2%,4%cream · topical, vaginalMEDTECH PRODUCTSOver-the-counter2 Feb 2001
MONISTAT 1 COMBINATION PACK2%,1.2GMcream, insert · topical, vaginalMEDTECH PRODUCTSOver-the-counter29 Jun 2001
MICONAZOLE 3 COMBINATION PACK2%,4%cream · topical, vaginalPERRIGOOver-the-counter30 Mar 2004
MICONAZOLE 34%cream · vaginalSUN PHARMA CANADAOver-the-counter2 Mar 2005
MICONAZOLE NITRATE4%cream · vaginalPERRIGO R AND DOver-the-counter15 Jan 2010
ORAVIG50MGtablet · buccalGALT PHARMSPrescription16 Apr 2010
MICONAZOLE NITRATE2%,1.2GMcream, insert · topical, vaginalPERRIGO R AND DOver-the-counter2 Jun 2010
MICONAZOLE NITRATE2%cream · topical, vaginalPERRIGO R AND DOver-the-counter2 Jun 2010
MONISTAT-DERM2%cream · topicalINSIGHT PHARMSDiscontinued8 Jan 1974
MONISTAT10MG/MLinjectable · injectionJANSSEN PHARMADiscontinued4 Oct 1978
MONISTAT 5100MGtampon · vaginalPERSONAL PRODSDiscontinued27 Oct 1989

9 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MICATIN MICONAZOLE NITRATE CREAM 2% USP020858522 % / W/WCREAM · TOPICALWELLSPRING PHARMACEUTICAL CANADA CORP
MICATIN POWDER SPRAY - UNSCENTED 2%022303042 %AEROSOL · TOPICALWELLSPRING PHARMACEUTICAL CANADA CORP
MICONAZOLE 3 DAY OVULE TREATMENT 400MG02171775400 MGSUPPOSITORY · VAGINALVITA HEALTH PRODUCTS INC
MICONAZOLE NITRATE VAGINAL CREAM 2%022455462 %CREAM · VAGINALVITA HEALTH PRODUCTS INC
MICONAZOLE NITRATE VAGINAL CREAM USP, 2%022315332 % / %CREAM · VAGINALTARO PHARMACEUTICALS INC
MONISTAT 3 VAGINAL CREAM022440054 %CREAM · VAGINALINSIGHT PHARMACEUTICALS, LLC
MONISTAT 7 DUAL-PAK02126257100 MG / SUP; 2 %SUPPOSITORY; CREAM · TOPICAL; VAGINALINSIGHT PHARMACEUTICALS, LLC
MONISTAT 7 VAGINAL CREAM020843092 %CREAM · VAGINALINSIGHT PHARMACEUTICALS, LLC
MONISTAT DERM CREAM021265672 %CREAM · TOPICALINSIGHT PHARMACEUTICALS, LLC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFT MICONAZOLE 1 COMBO PACK$11.54805per EA23 Sep 2026
US NADACFT MICONAZOLE 3 COMBO PACK$0.41315per GM23 Sep 2026
US NADACFT MICONAZOLE 3 COMBO PACK$7.427per EA23 Sep 2026
US NADACFT MICONAZOLE 7 CREAM$0.1188per GM23 Sep 2026
US NADACGNP MICONAZOLE 1 COMBO PACK$11.54805per EA23 Sep 2026
US NADACGS MICONAZOLE 3 COMBO PACK$7.427per EA23 Sep 2026
US NADACGS MICONAZOLE 7 CREAM$0.1188per GM23 Sep 2026
US NADACMICONAZOLE 2% TOPICAL CREAM$0.12071per GM23 Sep 2026
US NADACMICONAZOLE 2% TOPICAL CREAM$0.20075per GM23 Sep 2026
US NADACMICONAZOLE 2% TOPICAL CREAM$0.0822per GM23 Sep 2026
US NADACMICONAZOLE 2% TOPICAL CREAM$0.07945per GM23 Sep 2026
US NADACMICONAZOLE 2% TOPICAL CREAM$0.11958per GM23 Sep 2026
NHS Drug TariffMiconazole 0.16% dry powder spray£5.75100 gram1 Oct 2026
NHS Drug TariffMiconazole 2% cream£5.8130 gram1 Oct 2026
NHS Drug TariffMiconazole 2% powder£4.8920 gram1 Oct 2026
NHS Drug TariffMiconazole 20mg/g oromucosal gel sugar free£5.7615 gram1 Oct 2026
NHS Drug TariffMiconazole 20mg/g oromucosal gel sugar free£4.9580 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.

WHO WHO Model List of Essential Medicines (2025)

  • 13.1. Dermatological medicines > Antifungal medicines · core
    Fungal infection of the skin
    Local > Topical > Cream: 2% (nitrate) | Local > Topical > Ointment: 2% (nitrate)

Safety signals and safety-related labeling changes

All safety entries for miconazole →

Combinations containing Miconazole

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.