FDA.reportPublic FDA data

Antifungal

Product NDC
67777-710
11-digit product format
677770710
Labeler code
67777
Product ID
67777-710_4d384385-f3c6-09ba-e063-6394a90aec7f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-24
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

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
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d384385-f3c5-09ba-e063-6394a90aec7fAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-710-01Antifungal5 g in 1 PACKETCREAM51
67777-710-01Antifungal144 in 1 BOXCREAM1441
67777-710-02Antifungal2 in 1 CASECREAM21
67777-710-03Antifungal113 g in 1 TUBECREAM1131
67777-710-04Antifungal6 in 1 BOXCREAM61
67777-710-05Antifungal4 in 1 CASECREAM41

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 24 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FortiniaCLOTRIMAZOLEThe Podiatree Company60ba6f8a-8617-d4f6-e053-2991aa0a4a712026-01-08WarningsExact identifier
application number: M005
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
application number: M005
Wet wipesWET WIPESShenzhen Shierjie Biological Engineering Co., LTD273b3ae2-6dec-31a4-e063-6294a90aca892026-01-07WarningsExact identifier
application number: M005
Bee Venom Fungal Nail Treatment LiquidBEE VENOM FUNGAL NAIL TREATMENTShenzhen Earth Surface Trading Co., Ltd.47c37468-ba5c-0d11-e063-6294a90ac5542026-01-06WarningsExact identifier
application number: M005
ProBliva Anti Fungal Shampoo.ANTIFUNGALCAVTECH HOLDING LLC47af9ff8-5d5c-4524-e063-6394a90ac91f2026-01-05WarningsExact identifier
application number: M005
Beauty Creations Pink Halo Hand Sanitizer MistETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.dda9f4cb-e431-4164-be61-0daf1a86d10f2026-01-04WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.477c971d-829f-5040-e063-6394a90a41e42026-01-03WarningsExact identifier
application number: M005
Nail Renovar PlusTOLNAFTATESOHM, Inc2c09925c-e63e-4d9b-8d76-b06bd2cba26c2026-01-02WarningsExact identifier
application number: M005
Natural Sense Full Body Cleansing TowelCLEANSING TOWELDr. Natural LLC4742eec4-b7a3-2c89-e063-6294a90a19fc2025-12-31WarningsExact identifier
application number: M005
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
application number: M005
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
application number: M005
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
application number: M005
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
application number: M005
CuraNails Antifungal PenUNDECYLENIC ACID 25%Quality Discount Inc.3e641d36-72f6-4682-bd31-f7cd04d857f22025-12-25WarningsExact identifier
application number: M005
Opti-Nail 2-in-1TOLNAFTATEKramer Laboratoriesbc8a5492-8bd0-4c80-a270-e4958aeb5ed62025-12-23WarningsExact identifier
application number: M005
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
application number: M005
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN4d384385-f3c5-09ba-e063-6394a90aec7f1
998483miconazole nitrate 20 MG/ML Topical CreamSCD4d384385-f3c5-09ba-e063-6394a90aec7f1
998483miconazole nitrate 2 % Topical CreamSY4d384385-f3c5-09ba-e063-6394a90aec7f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-710-01677770710015 g in 1 PACKET5 gHistorical
67777-710-02677770710022 BOX in 1 CASE (67777-710-02) / 144 PACKET in 1 BOX (67777-710-01) / 5 g in 1 PACKET2 box2026-03-24NoNoCurrent
67777-710-0367777071003113 g in 1 TUBE113 gHistorical
67777-710-04677770710046 in 1 BOXHistorical
67777-710-05677770710054 BOX in 1 CASE (67777-710-05) / 6 TUBE in 1 BOX (67777-710-04) / 113 g in 1 TUBE (67777-710-03) 4 box2026-03-24NoNoCurrent