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 8 of 51 · 1,004 matching rows.
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