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 48 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EVERLIT CARE Hand Sanitizer ETHYL ALCOHOL EVERLIT GLOBAL INC. b9909c59-02e7-4d6c-aa2b-206f1ab4d02c 2023-11-14 Warnings Exact identifier application number: M005 FLUSH Maximum Strength Antifungal formula UNDECYLENIC ACID Triple Point Group, LLC 1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5 2023-11-11 Warnings Exact identifier application number: M005 SIMPLY VITAL Antifungal Cream CLOTRIMAZOLE ALPHA PLANTS INC d3842de3-0d13-4dc2-920b-90a4b822bbb8 2023-11-11 Warnings Exact identifier application number: M005 CLARUS AC Antifungal Solution TOLNAFTATE Clinical Therapeutic Solutions 28ab9f1b-65cd-4405-a9a3-f3c9b836693d 2023-11-10 Warnings Exact identifier application number: M005 Signature Black Bottle Tea Tree Antifungal Foot and Body Wash TOLNAFTATE Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) 2c966d97-30f5-4942-b64d-742884ce6a2f 2023-11-10 Warnings Exact identifier application number: M005 Smooth Gator Fungus Eliminator CLOTRIMAZOLE Smooth Gator, LLC 262b04f5-1b5d-4c67-a557-01f8b1711302 2023-11-10 Warnings Exact identifier application number: M005 TOLNAFTATE ANTIFUNGAL TOLNAFTATE Geri-Care Pharmaceuticals, Corp f9e60430-eec1-4bc2-9522-eb5aa527d90a 2023-11-08 Warnings Exact identifier application number: M005 Terrasil Jock Itch Treatment Maximum Strength CLOTRIMAZOLE Aidance Skincare & Topical Solutions, LLC c62fbf23-5d19-44ab-9c1a-e9b803192ed0 2023-11-08 Warnings Exact identifier application number: M005 terrasil The Fungal Solution Kit CLOTRIMAZOLE Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 9a5eb581-62a2-41fe-a174-e852fc47e235 2023-11-08 Warnings Exact identifier application number: M005 EmoniNail Antifungal UNDECYLENIC ACID GG Healthworks Inc. 84ace47a-d3ae-4735-87b6-dbbf1c40cf54 2023-11-06 Warnings Exact identifier application number: M005 CIDACIN Antifungal Treatment TOLNAFTATE Pedicis Research LLC bd53a9e3-65c8-4834-8e23-a2a928b83a66 2023-11-05 Warnings Exact identifier application number: M005 MacerRx Web MICONAZOLE NITRATE Clinical Therapeutic Solutions c9327f41-10f1-41f3-855b-838c701d6767 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 7e8897ff-67d1-4336-866e-cb76a36edddc 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 308a91d1-3511-4e2d-a62f-a31d77d70e06 2023-11-05 Warnings Exact identifier application number: M005 Human Science Antifungal Foot Care UNDECYLENIC ACID HUMAN SCIENCE, LLC 26b2519b-7d7b-4b33-b5d6-a41fe6f73538 2023-11-05 Warnings Exact identifier application number: M005 HomeHealth Antifungal TOLNAFTATE Home Health 895cd24c-3f78-4e2e-bf98-8bb6605798da 2023-11-05 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Proficient Rx LP 800a9dab-d287-427e-af6d-26996e0def41 2023-11-01 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE-IODINE Dr Radows 58e1757c-45ce-455e-bd64-a9e99cd3680f 2023-10-30 Warnings Exact identifier application number: M005 JOCK-EZE CLOTRIMAZOLE Bentlin Products LLC d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280 2023-10-30 Warnings Exact identifier application number: M005 TheraPlus Plus CLOTRIMAZOLE Zhejiang Jingwei Pharmaceutical Co., Ltd. de75179d-1889-4823-9f39-4bebdf185d76 2023-10-27 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