Home NDC 51672-2001 Miconazole Nitrate
Product NDC 51672-2001
11-digit product format 516722001
Labeler code 51672
Product ID 51672-2001_59d8ccc0-136d-dfa7-e063-6394a90adde1
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 1991-10-01
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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 20 mg/g
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 998483 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 51672-2001-1 Miconazole Nitrate 1 in 1 CARTON CREAM 1 5 51672-2001-1 Miconazole Nitrate 15 g in 1 TUBE CREAM 15 5 51672-2001-2 Miconazole Nitrate 1 in 1 CARTON CREAM 1 5 51672-2001-2 Miconazole Nitrate 30 g in 1 TUBE CREAM 30 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Miconazole Nitrate ACTIVE INGREDIENT VW4H1CYW1K MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Miconazole ACTIVE MOIETY 7NNO0D7S5M MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 apricot kernel oil INACTIVE INGREDIENT 54JB35T06A MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 benzoic acid INACTIVE INGREDIENT 8SKN0B0MIM MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 butylated hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycol stearate INACTIVE INGREDIENT 0324G66D0E MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 PEG-32 stearate INACTIVE INGREDIENT 33GX5WQC0M MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 PEG-6 stearate INACTIVE INGREDIENT 8LQC57C6B0 MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 polyethylene glycol 300 INACTIVE INGREDIENT 5655G9Y8AQ MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2001 MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, Legacy NDC, 4 package rows 20241222_7fd4037e-d350-47b7-a7d9-a43b8e366fa0.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 17 of 51 · 1,004 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fungicure Anti-Fungal Liquid TOLNAFTATE Kobayashi Healthcare International, Inc. b18ee199-0659-733c-e053-2a95a90ab6b5 2026-04-01 Warnings Exact identifier application number: M005 Tolnaftate ANTIFUNGAL LIQUID SPRAY CVS Pharmacy 96cc594d-85c8-4f62-bc0a-3176c8739f21 2026-04-01 Warnings Exact identifier application number: M005 Tolnafate TOLNAFTATE POWDER SPRAY CVS Pharmacy a7b6bd7c-23db-43e1-92f7-e27f5f4801de 2026-04-01 Warnings Exact identifier application number: M005 Baza Antifungal MICONAZOLE NITRATE Coloplast Corp 75182cb7-840a-423a-9c20-10840d6e1d65 2026-03-31 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Trifecta Pharmaceuticals Usa Llc 80217dbb-a0f0-414a-8d22-a9a346b017aa 2026-03-31 Warnings Exact identifier application number: M005 RoyceDerm Antifungal Bar CLOTRIMAZOLE RoyceDerm LLC 3abdc4a8-58dd-5bd0-e063-6294a90a1bca 2026-03-31 Warnings Exact identifier application number: M005 Critic Aid Clear AF MICONAZOLE NITRATE Coloplast Corp cbc5d976-850a-476e-b179-b7a5a8675524 2026-03-31 Warnings Exact identifier application number: M005 Velloryn ANTIFUNGAL Cream ZINC UNDECYLENATE, UNDECYLENIC ACID Guangdong Quadrant Ecological Technology Co., Ltd. 4e38e1f1-0466-5b91-e063-6294a90a66c4 2026-03-30 Warnings Exact identifier application number: M005 APUREE Nailtific Extra-Max Strength Daytime Antigungal APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL Guangzhou Meixi Biotechnology Co., Ltd. 4e3d226b-57f1-75a6-e063-6394a90a96cd 2026-03-30 Warnings Exact identifier application number: M005 APUREE Nailtific Extra-Max Strength Nighttime Antifungal APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL Guangzhou Meixi Biotechnology Co., Ltd. 4e3e8895-34b4-de69-e063-6294a90a5532 2026-03-30 Exact identifier application number: M005 Miconazole Nitrate ATHLETES FOOT POWDER SPRAY TALC FREE CVS Pharmacy 3380263d-ee7b-4946-a467-35a24789a901 2026-03-27 Warnings Exact identifier application number: M005 Micro-Guard (AF) MICONAZOLE NITRATE Coloplast Corp a43a94d0-fec0-470f-bdb4-535dcce6d1e0 2026-03-27 Warnings Exact identifier application number: M005 Suave Antibacterial Hand Wash Fresh Citrus LIQUID HAND WASH ANTIBACTERIAL Suave Brands Co, LLC 41d77ec6-a1d1-13dc-e063-6394a90a95f4 2026-03-26 Warnings Exact identifier application number: M005 Suave Antibacterial Hand Wash Deeply Clean LIQUID HAND WASH ANTIBACTERIAL Suave Brands Co, LLC 41d83736-66da-abb9-e063-6294a90a3d67 2026-03-26 Warnings Exact identifier application number: M005 Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera LIQUID HAND WASH ANTIBACTERIAL Suave Brands Co, LLC 41d8848c-d157-6e2c-e063-6294a90aa259 2026-03-26 Warnings Exact identifier application number: M005 Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch ANTIFUNGAL TREATMENT KIT Beautivity LLC 4800a93b-7042-827b-e063-6294a90acd95 2026-03-25 Warnings Exact identifier application number: M005 Toenail Fungus Treatment TERBINAFINE Shenzhen Wankelai E-commerce Co., Ltd. 4dc1d7f7-e4ae-c54b-e063-6394a90aa420 2026-03-24 Warnings Exact identifier application number: M005 Lasolex Liquid Solution CLOTRIMAZOLE 1% PureTek Corporation 4dc9e64d-8235-b218-e063-6394a90a0157 2026-03-24 Warnings Exact identifier application number: M005 Hermon Jock Itch Antifungal Treatment .Soap. Bar TOLNAFTATE 1% Beautivity LLC 4dbbf09b-5bc1-501b-e063-6394a90a2a9d 2026-03-23 Warnings Exact identifier application number: M005 Hermon Jock Itch Antifungal Treatment Cream MICONAZOLE NITRATE 2% Beautivity LLC 4dbc521c-2f5f-9736-e063-6294a90ad85d 2026-03-23 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 Marketing end Sample Exclude flag Status 51672-2001-1 51672200101 1 TUBE in 1 CARTON (51672-2001-1) / 15 g in 1 TUBE 1 tube 1991-10-01 0000-00-00 No No Current 51672-2001-2 51672200102 1 TUBE in 1 CARTON (51672-2001-2) / 30 g in 1 TUBE 1 tube 1991-10-01 0000-00-00 No No Current