FDA.reportPublic FDA data

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#

Effective, Related label table
EffectiveRelated label
2023-01-12CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2023-01-12CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2023-01-12CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2021-07-23CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2021-07-23CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2021-07-23CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free

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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact 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