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 23 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer HealthCare LLC.1300d84f-d7ff-ec57-e063-6294a90ae0de2026-01-16WarningsExact identifier
application number: M005
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4868de4b-65ea-01ed-e063-6294a90ae5512026-01-15WarningsExact identifier
application number: M005
Antifungal Ringworm TreatmentMICONAZOLE NITRATERida LLCeb953281-cf86-44cf-a3d1-37b8d344a6bc2026-01-15WarningsExact identifier
application number: M005
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA483f3199-7357-112c-e063-6394a90aafa42026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA48555528-bbbc-ccef-e063-6294a90a66092026-01-14WarningsExact identifier
application number: M005
HERMON ANTIFUNGAL BARTOLNAFTATEHaikou Pucao Trading Co.,Ltd2da7a20e-021e-2111-e063-6294a90ad4412026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4866d108-0bbb-12bf-e063-6394a90a338c2026-01-14WarningsExact identifier
application number: M005
Hermon Ringworm Treatment Body WashTOLNAFTATE 1%Beautivity LLC48417be9-7cc0-e2f3-e063-6294a90aa2a22026-01-13WarningsExact identifier
application number: M005
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
application number: M005
Zeasorb Jock ItchMICONAZOLE NITRATECrown Laboratories09d088ef-aab3-5565-e063-6394a90af2632026-01-12WarningsExact identifier
application number: M005
Zeasorb Athletes FootMICONAZOLE NITRATECrown Laboratories09bb313e-90cb-5629-e063-6294a90ac2682026-01-12WarningsExact identifier
application number: M005
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsExact identifier
application number: M005
BZK Antiseptic SwabBENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.94043f4e-fe47-4b6f-8354-30697daaed812026-01-12WarningsExact identifier
application number: M005
miconazole nitrateMICONAZOLE NITRATEAvPAKeaf016f6-b631-af00-e053-2a95a90adc7b2026-01-09WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company68a4e3f5-f84d-5650-e053-2a91aa0a171d2026-01-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company79234400-0766-792c-e053-2a91aa0a6e6d2026-01-08WarningsExact identifier
application number: M005
FortiniaCLOTRIMAZOLE 1%The Podiatree Companya003130b-77f7-4d42-8e7f-edd55176f0132026-01-08WarningsExact identifier
application number: M005
Fortinia OFCLOTRIMAZOLE 1%The Podiatree Company60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f2026-01-08WarningsExact 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