FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
59779-097
11-digit product format
597790097
Labeler code
59779
Product ID
59779-097_4a6974e2-1868-d36c-e063-6394a90a2edb
Type
HUMAN OTC DRUG
Nonproprietary name
Athletes Foot Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
MICONAZOLE NITRATE
Active strength
3 g/150g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole Nitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE3 g/150g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998533Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-097-53Miconazole Nitrate150 g in 1 CANAEROSOL, SPRAY15013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-097-53GM - Gram59779-097fcf973de-4b80-4170-a497-e229f22141a312020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ACETONEINACTIVE INGREDIENT1364PS73AFMICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BMICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-097MICONAZOLE NITRATE (ATHLETES FOOT SPRAY) AEROSOL, SPRAY [CVS PHARMACY]11Current NDC, Legacy NDC, 1 package rows20241109_1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 27 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Myco Nail A Antifungal SolutionUNDECYLENIC ACIDKramer Novis550358d7-69e8-4ea3-bcf9-d647c457287d2025-12-04WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal SoapsTOLNAFTATENanjing Jitaxing Technology Co., LTD4517d3a7-9144-b91d-e063-6294a90a49902025-12-03WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions23ca78c0-16a9-455c-99a7-b9a9a3affa602025-12-03WarningsExact identifier
application number: M005
Gembooxt Nail Fungus SolutionGEMBOOXT NAIL FUNGUS SOLUTIONGuangdong Quadrant Ecological Technology Co., Ltd.44f5c1bc-decf-beef-e063-6394a90ab5622025-12-02WarningsExact identifier
application number: M005
WELMATE Clotrimazole Topical SolutionCLOTRIMAZOLEYYBA CORPdc5bac4a-938c-4678-89ac-a899440c6a3c2025-12-02WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATECARDINAL HEALTH 110 dba LEADERbb14825c-518d-bfba-e053-2995a90a78892025-12-02WarningsExact identifier
application number: M005
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d375325-ddad-f1e1-e063-6394a90a679f2025-12-01WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc0a6cb1f7-a2a2-46a2-ae63-d205318996f02025-12-01WarningsExact identifier
application number: M005
CAREALL Miconazole NitrateMICONAZOLE NITRATENew World Imports, Incbed775be-8bcb-44c2-9b9f-8bb25b4b24532025-12-01WarningsExact identifier
application number: M005
CAREALL TolnaftateTOLNAFTATENew World Imports, Inccabf84c1-1500-46fe-b226-b16d4a0666c72025-12-01WarningsExact identifier
application number: M005
TrimazoleCLOTRIMAZOLETrifluent Pharma LLCa3bafc52-1404-4e0b-84c1-e28bffcb091e2025-12-01WarningsExact identifier
application number: M005
APUREE Pure Nailtific Extra-Strength Fungal Nail PatchesAPUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.445354d8-bec2-0fd9-e063-6394a90a00992025-11-24WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEVALU MERCHANDISERS, COf4abb499-6893-9efb-e053-2995a90a33ed2025-11-24WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREEVALU MERCHANDISERS, CO9ac97d4a-169b-49ff-aa34-ccb5b43726a12025-11-24WarningsExact identifier
application number: M005
TolnafateFOOT ODOR CONTROL POWDER SPRAYVALU MERCHANDISERS, CO51b69b0f-d63f-4fe0-87e6-722f955687612025-11-24WarningsExact identifier
application number: M005
Miconazole Nitrate Antifungal PowderMICONAZOLE NITRATE ANTIFUNGAL POWDERMarlex Pharmaceuticals, Inc.de4f703c-39e9-855e-e053-2a95a90a6ea92025-11-21WarningsExact identifier
application number: M005
Odor-Eaters Athletes FootTOLNAFTATEBlistex Inc.20d795d1-2345-4d4f-8439-07ad11ff8f652025-11-21WarningsExact identifier
application number: M005
Derman AntifungalZINC UNDECYLENATECompania Internacional de Comercio, S.A.P.I de C.V.0129d801-90f6-49fd-857f-27d6ba9fc66c2025-11-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions9afb964c-9b88-4701-adcf-7070e25cb6c12025-11-19WarningsExact identifier
application number: M005
AU KAH CHUEN ANTIFUNGALCLOTRIMAZOLEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.3a262bcd-e6c0-4554-ab1c-9c861f90e1902025-11-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998533miconazole nitrate 2 % Topical SprayPSN1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c13
998533miconazole nitrate 20 MG/ML Topical SpraySCD1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c13
998533miconazole nitrate 2 % Topical SpraySY1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c13
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-097-5359779009753150 g in 1 CAN (59779-097-53) 150 g2014-01-010000-00-00NoNoCurrent