Miconazole Nitrate

Product NDC
41520-565
11-digit product format
415200565
Labeler code
41520
Product ID
41520-565_458ac437-bfd6-73c7-e063-6294a90afc9b
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-fungal Miconazole Athletes Foot Spray Talc Free
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Foodhold USA
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-20
Substance
MICONAZOLE NITRATE
Active strength
2.6 g/130g
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41520-565-46fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41520-565-4686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41520-565-46bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41520-565-468dfbde2a14a4…c9ff85d89658…

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 NITRATE2.6 g/130g

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
998428Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a64c9371-0ac7-4c47-bc12-7bc77162b244Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-565-46Miconazole Nitrate130 g in 1 CANAEROSOL, POWDER1307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-565MICONAZOLE NITRATE (ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE) AEROSOL, POWDER [FOODHOLD USA]5Current NDC, Legacy NDC, 1 package rows20241109_a64c9371-0ac7-4c47-bc12-7bc77162b244.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 8 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998428miconazole nitrate 2 % Powder SprayPSNa64c9371-0ac7-4c47-bc12-7bc77162b2447
998428miconazole nitrate 0.02 MG/MG Powder SpraySCDa64c9371-0ac7-4c47-bc12-7bc77162b2447
998428miconazole nitrate 2 % Powder SpraySYa64c9371-0ac7-4c47-bc12-7bc77162b2447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-565-4641520056546130 g in 1 CAN (41520-565-46) 130 g2017-10-200000-00-00NoNoCurrent