Home NDC 0536-1375 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Product NDC 0536-1375
11-digit product format 005361375
Labeler code 0536
Product ID 0536-1375_297d80f9-921c-0850-e063-6294a90a721a
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form CREAM
Route TOPICAL
Labeler Rugby
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-07
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 2% Cream ANTIFUNGAL
Listing expiration 2026-12-31 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 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 0536-1375-75 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 1 in 1 BOX CREAM 1 2 0536-1375-75 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 28.3 g in 1 TUBE CREAM 28.3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1375 MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [RUGBY] 2 Current NDC, 2 package rows 20241220_f420de00-408f-9a2c-e053-2995a90adced.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 Sample Exclude flag Status 0536-1375-75 00536137575 1 TUBE in 1 BOX (0536-1375-75) / 28.3 g in 1 TUBE 1 tube 2023-02-07 No No Current