FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
72446-014
11-digit product format
724460014
Labeler code
72446
Product ID
72446-014_41eec725-8a57-1cd8-e063-6294a90a9221
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Powder Miconazole Nitrate Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
Hudson Health LLC
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
36ec5f05-5d1c-25df-e063-6394a90a9dd9Available 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
72446-014-01Miconazole 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 5 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
application number: M005
OURUI ONE FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a473f03-f4cc-74ef-e063-6394a90ac7072026-07-20WarningsExact identifier
application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
application number: M005
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
application number: M005
Vamy ANTIFUNGALTOLNAFTATE 1% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4dfdf3a2-95a8-9176-e063-6294a90a64de2026-07-20WarningsExact identifier
application number: M005
Antifungal creamANTIFUNGAL CREAMShenzhen Earth Surface Trading Co., Ltd.5708cc16-9a26-fd3c-e063-6394a90ac0ee2026-07-20WarningsExact identifier
application number: M005
TrpWinner TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523c2a9c-3b35-bf73-e063-6394a90ae17d2026-07-20WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD4ac347b5-d21b-cc9a-e063-6394a90a54962026-07-20WarningsExact identifier
application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGALCLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4ac31b1d-59d7-f45c-e063-6294a90a0d3d2026-07-20WarningsExact identifier
application number: M005
IraEvanes ANTIFUNGAL FOOTTOLNAFTATE 1% ANTIFUNGAL FOOTJiangxi Yudexi Pharmaceutical Co., LTD4d851a99-a453-e829-e063-6294a90a91182026-07-20WarningsExact identifier
application number: M005
LYSSERA Fungal Nail RenewalUNDECYLENIC ACID 25% ANTIFUNGAJiangxi Yudexi Pharmaceutical Co., LTD4dea6df4-e66b-c24a-e063-6294a90afca72026-07-20WarningsExact identifier
application number: M005
Kakalsa TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD5123c0c3-bba8-d61c-e063-6394a90aab702026-07-20WarningsExact identifier
application number: M005
SOVS FUNGAL NAIL REPAIR RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWALJiangxi Yudexi Pharmaceutical Co., LTD536b0c48-691e-755b-e063-6294a90a778e2026-07-20WarningsExact identifier
application number: M005
Tea Tree AntifungalCLOTRIMAZOLEHONG KONG UNORDERED TRADING CO., LIMITED56de35b7-b57d-1c62-e063-6294a90a757d2026-07-18WarningsExact identifier
application number: M005
ACTIV-CHARCOAL ANTIFUNGALTOLNAFTATEHONG KONG UNORDERED TRADING CO., LIMITED56def103-40ef-cd88-e063-6394a90a07172026-07-18WarningsExact identifier
application number: M005
SOVS MULTI-PURPOSE NAIL REPAIRTOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIRWenzhou Yuyuan Pharmaceutical Co., Ltd.56df87a7-7fc2-5ba4-e063-6394a90a652b2026-07-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN36ec5f05-5d1c-25df-e063-6394a90a9dd92
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD36ec5f05-5d1c-25df-e063-6394a90a9dd92
998461miconazole nitrate 2 % Topical PowderSY36ec5f05-5d1c-25df-e063-6394a90a9dd92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72446-014-017244600140171 g in 1 BOTTLE, PLASTIC (72446-014-01) 71 g2025-06-06NoNoCurrent