Home NDC 65197-103 Micatin
Product NDC 65197-103
11-digit product format 651970103
Labeler code 65197
Product ID 65197-103_d9d5ec5c-ee44-42cd-9579-969f3ae1f166
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate
Dosage form CREAM
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-06-24
Marketing end 2026-11-30
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
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 Micatin 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998483 Internal RxNorm lookup 998509 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 65197-103-05 Micatin 14 g in 1 TUBE CREAM 14 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-103 MICATIN (MICONAZOLE NITRATE) CREAM [WELLSPRING PHARMACEUTICAL CORPORATION] 11 Current NDC, Legacy NDC, 1 package rows 20240711_96c56ba1-c3a8-48ce-ab58-550959485e3c.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 49 · 973 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 65197-103-05 65197010305 14 g in 1 TUBE (65197-103-05) 14 g 2009-06-24 2026-11-30 No No Current