Home NDC 42291-938 Miconazole Nitrate
Product NDC 42291-938
11-digit product format 422910938
Labeler code 42291
Product ID 42291-938_48c0e508-e6c0-3d43-e063-6294a90a3ade
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form POWDER
Route TOPICAL
Labeler AvKARE
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-05
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 Miconazole Nitrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998461 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-938-85 Miconazole Nitrate 85 g in 1 BOTTLE POWDER 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-938 MICONAZOLE NITRATE POWDER [AVKARE] 1 Current NDC, 1 package rows 20240615_1a26534d-eeb8-8d17-e063-6294a90a70c7.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 24 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fortinia CLOTRIMAZOLE The Podiatree Company 60ba6f8a-8617-d4f6-e053-2991aa0a4a71 2026-01-08 Warnings Exact identifier application number: M005 RoyceDerm Anti fungal RELIEF cream SALICYLIC ACID 2% RoyceDerm LLC 47ec6277-e40f-af82-e063-6294a90ac8c1 2026-01-08 Warnings Exact identifier application number: M005 BBlove ALCOHOL WIPES BBLOVE ALCOHOL WIPES Shenzhen Shierjie Biological Engineering Co., LTD 1a451616-b16e-8aa7-e063-6294a90a26a1 2026-01-07 Warnings Exact identifier application number: M005 Wet wipes WET WIPES Shenzhen Shierjie Biological Engineering Co., LTD 273b3ae2-6dec-31a4-e063-6294a90aca89 2026-01-07 Warnings Exact identifier application number: M005 Bee Venom Fungal Nail Treatment Liquid BEE VENOM FUNGAL NAIL TREATMENT Shenzhen Earth Surface Trading Co., Ltd. 47c37468-ba5c-0d11-e063-6294a90ac554 2026-01-06 Warnings Exact identifier application number: M005 ProBliva Anti Fungal Shampoo. ANTIFUNGAL CAVTECH HOLDING LLC 47af9ff8-5d5c-4524-e063-6394a90ac91f 2026-01-05 Warnings Exact identifier application number: M005 Beauty Creations Pink Halo Hand Sanitizer Mist ETHYL ALCOHOL Nantong Health & Beyond Hygienic Products Inc. dda9f4cb-e431-4164-be61-0daf1a86d10f 2026-01-04 Warnings Exact identifier application number: M005 FUNGAL NAIL PATCHES UNDECYLENIC ACID Guangzhou Hechuang Commercial Service Co.,Ltd. 477c971d-829f-5040-e063-6394a90a41e4 2026-01-03 Warnings Exact identifier application number: M005 Nail Renovar Plus TOLNAFTATE SOHM, Inc 2c09925c-e63e-4d9b-8d76-b06bd2cba26c 2026-01-02 Warnings Exact identifier application number: M005 Natural Sense Full Body Cleansing Towel CLEANSING TOWEL Dr. Natural LLC 4742eec4-b7a3-2c89-e063-6294a90a19fc 2025-12-31 Warnings Exact identifier application number: M005 Lasolex AG MICONAZOLE NITRATE Puretek Corporation 4411142f-a8ec-c8c2-e063-6394a90aa25c 2025-12-31 Warnings Exact identifier application number: M005 Hermon Antifungal Stick 1% CLOTRIMAZOLE Beautivity LLC 474a5783-4488-034e-e063-6294a90a5de3 2025-12-31 Warnings Exact identifier application number: M005 SnugZ Hand Sanitizing Wipes HAND SANITIZING WIPES SnugZ/USA, LLC c5d9122a-2c67-2387-e053-2a95a90a2c3a 2025-12-29 Warnings Exact identifier application number: M005 Clotrimazole (Topical Solution), 1% CLOTRIMAZOLE Puro Pharma Inc. cb424fa8-3ed5-45cd-b03f-64675584b34e 2025-12-27 Warnings Exact identifier application number: M005 CLOTRIMAZOLE CLOTRIMAZOLE GRAXCELL PHARMACEUTICAL, LLC. 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99 2025-12-25 Warnings Exact identifier application number: M005 CuraNails Antifungal Pen UNDECYLENIC ACID 25% Quality Discount Inc. 3e641d36-72f6-4682-bd31-f7cd04d857f2 2025-12-25 Warnings Exact identifier application number: M005 Opti-Nail 2-in-1 TOLNAFTATE Kramer Laboratories bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 2025-12-23 Warnings Exact identifier application number: M005 ProBliva Medicated Anti Fungal ANTIFUNGAL CAVTECH HOLDING LLC 46852aea-028c-71c2-e063-6394a90a8055 2025-12-22 Warnings Exact identifier application number: M005 Terthon Clotrimazole 1% Antifungal Cream CLOTRIMAZOLE 1% SOLALIA LLC 468f1b1b-f67d-8b98-e063-6294a90a7f45 2025-12-22 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Granules USA, Inc. 6e63e29a-eb50-1790-e053-2a91aa0a3616 2025-12-22 Warnings Exact identifier application number: M005
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-938-85 42291093885 85 g in 1 BOTTLE (42291-938-85) 85 g 2024-06-05 No No Current