FDA.reportPublic FDA data

Anti-fungal Powder Miconazole Nitrate

Product NDC
79481-0621
11-digit product format
794810621
Labeler code
79481
Product ID
79481-0621_4276f9c7-a8dd-6ab4-e063-6394a90a234f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-28
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
Anti-fungal Powder 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
03fd069d-685d-b8ac-e063-6394a90a31f8Available 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
79481-0621-1Anti-fungal Powder Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER716

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0621ANTI-FUNGAL POWDER MICONAZOLE NITRATE (MICONAZOLE NITRATE) POWDER [MEIJER DISTRIBUTION INC]5Current NDC, 1 package rows20241016_03fd069d-685d-b8ac-e063-6394a90a31f8.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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005
Micotrin ALTOLNAFTATEPureTek Corporationcc0fba1e-82c5-42fd-e053-2995a90af2492024-10-02WarningsExact identifier
application number: M005
Mycozyl ALTOLNAFTATEPureTek Corporationb82c9a8a-f6f1-dca6-e053-2995a90a47f92024-10-02WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.f19971b1-2aeb-4c37-82b0-9525026cff7a2024-10-02WarningsExact identifier
application number: M005
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
application number: M005
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
application number: M005
Mycozyl ACCLOTRIMAZOLEPureTek Corporationb676d257-3cfd-7f24-e053-2995a90a546e2024-10-01WarningsExact identifier
application number: M005
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
application number: M005
AOSI HEALTHCARE HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.59d631d0-d8ae-45a8-a7a9-26de9cc427b32024-09-25WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEDabur India Limited22916978-303f-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M005
Mentholatum Heel Revival CreamMENTHOLATUM HEEL REVIVAL CREAMThe Mentholatum Company21b643c2-eb6e-8939-e063-6394a90aaeac2024-09-09WarningsExact identifier
application number: M005
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Tropical Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.3645359c-06a2-4b97-b982-c54e4a0b8cda2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Coastal Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.645c09dc-15a4-481f-a605-f12fb8f8e9bd2024-09-04WarningsExact identifier
application number: M005
Publix Athletic FootCLOTRIMAZOLE 1%PUBLIX SUPER MARKETS, INC.d9f99680-5636-4136-a7c6-c3643339e6b42024-08-02WarningsExact identifier
application number: M005
ANTIFUNGAL FOOTTOLNAFTATEUniversal Distribution Center LLC10579848-5793-4d72-ad5f-62d191c710742024-07-16WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf32024-07-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN03fd069d-685d-b8ac-e063-6394a90a31f86
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD03fd069d-685d-b8ac-e063-6394a90a31f86
998461miconazole nitrate 2 % Topical PowderSY03fd069d-685d-b8ac-e063-6394a90a31f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0621-17948106210171 g in 1 BOTTLE, PLASTIC (79481-0621-1) 71 g2024-03-18NoNoCurrent