FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
53943-976
11-digit product format
539430976
Labeler code
53943
Product ID
53943-976_42536dcc-b1cc-fe45-e063-6394a90ae319
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Discount Drug Mart, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-03
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37790bf8-6114-84b9-e063-6394a90ad58dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-976-01Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER712

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 30 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateJOCK ITCH SPRAYKroger Co.86bdf8a6-3a1f-457b-e053-2991aa0a58102025-10-30WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE POWDER SPRAYKroger Co.f5c8dccd-8e69-6a01-e053-2a95a90a69722025-10-30WarningsExact identifier
application number: M005
TolnafateFOOT AND SNEAKER SPRAYKroger Co.72243b08-47cf-4db3-b834-b762b7f0ccf92025-10-30WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATEThe Kroger Co.209cd0ed-3029-9137-e063-6394a90aa93d2025-10-30WarningsExact identifier
application number: M005
Antifungal Miconazole Liquid ContinuousMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-334b-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005
Jock ItchMICONAZOLE NITRATEMeijer Distribution Inc.030f1316-ab3c-ce37-e063-6394a90a0f882025-10-30WarningsExact identifier
application number: M005
Antifungal Athletes FootMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-3357-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYMeijer Distribution Inc.0370c9fa-b986-3a63-e063-6294a90a76272025-10-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYMeijer Distribution Inc.0423c895-6841-fcd0-e063-6394a90ad7872025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYWinco Foods, LLCcc24f4ca-a403-0dc4-e053-2a95a90a5dad2025-10-29WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWinco Foods, LLCcc251fab-b66c-44f4-e053-2995a90a681a2025-10-29WarningsExact identifier
application number: M005
Remedy AntifungalMICONAZOLE NITRATEMedline Industries, LP021b4a31-d7f6-4921-b4b1-cbe832eecd932025-10-29WarningsExact identifier
application number: M005
Family Care AntifungalTOLNAFTATEUnited Exchange Corp.6301ab99-1757-144a-e053-2a91aa0adb772025-10-29WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEDiscount Drug Mart, Inc37790bf8-6114-84b9-e063-6394a90ad58d2025-10-29WarningsExact identifier
application number: M005
ndc (product): 53943-976
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.052d8d02-2381-1e3a-e063-6394a90aa07e2025-10-29WarningsExact identifier
application number: M005
CVS Health Athletes FootTOLNAFTATECVS Pharmacy, Inc.ab746148-1111-15bc-e053-2a95a90a61f12025-10-29WarningsExact identifier
application number: M005
WinCo Foods AntifungalCLOTRIMAZOLEWinco Foods LLCc2ca0787-267a-10f4-e053-2a95a90a3a332025-10-28WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAY TALC FREEAmerican Sales Company4354b71e-6268-440d-b916-0403c6fc3ddb2025-10-27WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYFoodhold USA5a8427c2-a1b2-44aa-afb3-669c12efed282025-10-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDFSA Store Inc.fb34c5ae-2c6d-700d-e053-6394a90a909f2025-10-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN37790bf8-6114-84b9-e063-6394a90ad58d2
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD37790bf8-6114-84b9-e063-6394a90ad58d2
998461miconazole nitrate 2 % Topical PowderSY37790bf8-6114-84b9-e063-6394a90ad58d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-976-015394309760171 g in 1 BOTTLE, PLASTIC (53943-976-01) 71 g2025-06-13NoNoCurrent