FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
50090-1071
11-digit product format
500901071
Labeler code
50090
Product ID
50090-1071_9d2b1e85-ac93-4e13-8da5-554d79bcc38c
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-10-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1071-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1071-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1071-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1071-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1071-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1071-0557ba5c1ecfa…9c80585c8c6e…

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
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf131f33-3ab2-4f43-add5-920e78ac36a7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1071-0Miconazole Nitrate15 g in 1 TUBECREAM154
50090-1071-0Miconazole Nitrate1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1071-0GM - Gram50090-1071395b2dfa-4acf-4c40-8232-371fc8edf06112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1071MICONAZOLE NITRATE CREAM [A-S MEDICATION SOLUTIONS]4Current NDC, 2 package rows20250226_bf131f33-3ab2-4f43-add5-920e78ac36a7.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 18 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsExact identifier
application number: M005
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriese21ccb83-54ff-4605-80bf-7b4b789c7cb72026-03-17WarningsExact identifier
application number: M005
Peunitory Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.4d2e86bc-5122-ba4a-e063-6394a90acf132026-03-16WarningsExact identifier
application number: M005
DRMITSUI FOOT ANTIFUNGAL TREATMENTSALICYLIC ACIDZhenping Renren Industry Co., Ltd.4ce59d31-56fe-d74f-e063-6294a90a7cce2026-03-14WarningsExact identifier
application number: M005
NERANTE FUNGUS NAIL PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3984b-53cd-a665-e063-6394a90afe5f2026-03-13WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENTUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3f0e2-b532-b89f-e063-6294a90a7e252026-03-13WarningsExact identifier
application number: M005
BYT BANGYTONG HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShenzhen Jindali Technology Co., Ltd49ed1cc8-e8e5-399c-e063-6394a90a044a2026-03-10WarningsExact identifier
application number: M005
Natouch Antifungal Wipes PlusANTIFUNGAL ANTISEPTIC WIPES PLUSNatouch LLCa85cb307-b3ad-1584-e053-2995a90a9a702026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb6fdfd-116e-14e9-e063-6294a90a4de32026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b2026-03-10WarningsExact identifier
application number: M005
SootheSense Toenail Fungus TreatmentUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca2bbeb-3b8a-9482-e063-6294a90a57892026-03-09WarningsExact identifier
application number: M005
Natouch Antifungal Antiseptic WipesANTIFUNGAL ANTISEPTIC WIPESNatouch LLC4c84c556-8d0b-ec28-e063-6294a90af1d32026-03-08WarningsExact identifier
application number: M005
ANTIFUNGAL CreamANGELICA DAHURICA EXTRACTT, ASIATIC ACIDGuangzhou Mizi Biotechnology Co., LTD.4c586cd9-d356-34d8-e063-6294a90a4d112026-03-06WarningsExact identifier
application number: M005
FungiFoamTOLNAFTATEThe Tetra Corporation2449e8e5-9d7e-4119-9e7a-378efe55f8752026-03-06WarningsExact identifier
application number: M005
RoyceDerm ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4c43e62b-9060-8962-e063-6394a90aff632026-03-05WarningsExact identifier
application number: M005
Derman AntifungalTOLNAFTATECompania Internacional de Comercio, S.A.P.I. de C.V.5784a783-1056-4d50-8d87-2df4f8e16b092026-03-05WarningsExact identifier
application number: M005
Antifungal PowderTOLNAFTATEARMY & AIR FORCE EXCHANGE SERVICE4c39e121-4919-a482-e063-6294a90a98cd2026-03-04WarningsExact identifier
application number: M005
ViLLsure Antifungal PenUNDECYLENIC ACID 25%ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD4c28cf04-94ad-8db6-e063-6394a90a2eed2026-03-03WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNbf131f33-3ab2-4f43-add5-920e78ac36a74
998483miconazole nitrate 20 MG/ML Topical CreamSCDbf131f33-3ab2-4f43-add5-920e78ac36a74
998483miconazole nitrate 2 % Topical CreamSYbf131f33-3ab2-4f43-add5-920e78ac36a74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1071-0500901071001 TUBE in 1 CARTON (50090-1071-0) / 15 g in 1 TUBE1 tube2014-11-28NoNoCurrent