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 36 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolnaftate AntifungalTOLNAFTATESTRATEGIC SOURCING SERVICES LLC97ffb6fd-5670-4783-b805-88fe9e43ca962025-07-15WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESTRATEGIC SOURCING SERVICES LLC966a1000-3b08-4f2c-a9f8-568f2524b7172025-07-15WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATEAmerisource Bergena3c9b783-4a36-46b3-a0dc-0696907eaebb2025-07-15WarningsExact identifier
application number: M005
Clotrimazole Jock ItchCLOTRIMAZOLERite Aid Corporationc2875c05-eedd-4546-89dd-ed88b3f28abd2025-07-14WarningsExact identifier
application number: M005
Signature Care Jock ItchCLOTRIMAZOLESafeway Inc.9ec8b527-0f03-4433-8d33-635e746fdf792025-07-14WarningsExact identifier
application number: M005
RingwormCLOTRIMAZOLEWalgreen Company42ee3ebc-4d8f-4ece-950d-5636699a2b2e2025-07-11WarningsExact identifier
application number: M005
Walgreens Jock ItchCLOTRIMAZOLEWalgreen Company2d6d7ac8-9f62-4670-9aa2-e73c29034de92025-07-11WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEWalgreen Company5cc1c525-8ff2-429b-97ec-129e0100db472025-07-11WarningsExact identifier
application number: M005
Live Better AntifungalCLOTRIMAZOLEThe Great Atlantic & Pacific Tea Company7b2e44b9-b1ac-48c8-994d-4e9682ec8bad2025-07-11WarningsExact identifier
application number: M005
CVS Antifungal RingwormCLOTRIMAZOLECVS Pharmacy638c7fd6-cec4-4c14-9f49-de56587211992025-07-11WarningsExact identifier
application number: M005
CVS Pharmacy ITCH RELIEF ANTIFUNGALCLOTRIMAZOLECVS Pharmacy68163ef4-d23d-43ac-bb52-9b4ba3cba2d02025-07-11WarningsExact identifier
application number: M005
HEB AntifungalCLOTRIMAZOLEH E B8f07dc5a-cfa8-4a57-ac90-552a7c947cc52025-07-11WarningsExact identifier
application number: M005
Publix athletic footCLOTRIMAZOLEPublix Super Markets Inca51679aa-5dd4-404a-98cf-cc620e233cb82025-07-11WarningsExact identifier
application number: M005
Terrasil Athletes Foot AntiFungal Treatment MaxCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfce478a0-05f5-4606-82ce-c8dd095df2112025-07-11WarningsExact identifier
application number: M005
Terrasil Tinea Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsd0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa2025-07-11WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLECVS Pharmacy8731f4ca-84a0-4325-895b-35bf8e2ff0e12025-07-08WarningsExact identifier
application number: M005
CAREONE ClotrimazoleCLOTRIMAZOLEAmerican Sales Company68915156-8927-4ace-9497-5e510d1edcca2025-07-08WarningsExact identifier
application number: M005
Clotrimazole Athletes FootCLOTRIMAZOLEWal-Mart Stores, Inc.1440cf4d-e075-4137-a8ee-f41bd449c9982025-07-08WarningsExact identifier
application number: M005
Good Neighbor Pharmacy ClotrimazoleCLOTRIMAZOLEAmerisourceBergenadf75d72-26a7-4f4e-bba5-34a6fbe2a4cc2025-07-08WarningsExact identifier
application number: M005
Kroger ATHLETES FOOTCLOTRIMAZOLEKroger Company9e623f18-3e00-4952-b347-337d83fe3acb2025-07-08WarningsExact 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