Home NDC 50090-5674 Miconazole Nitrate
Product NDC 50090-5674
11-digit product format 500905674
Labeler code 50090
Product ID 50090-5674_d80e0a1c-83db-44b9-94b6-5e2e83c630d5
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler A-S Medication Solutions
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-29
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5674-0 Miconazole Nitrate 1 in 1 CARTON CREAM 1 6 50090-5674-0 Miconazole Nitrate 28 g in 1 TUBE CREAM 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5674 MICONAZOLE NITRATE CREAM [A-S MEDICATION SOLUTIONS] 6 Current NDC, Legacy NDC, 2 package rows 20231212_7d284f6f-a970-49fe-b45a-d5c6c2688bc2.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 39 of 49 · 969 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 50090-5674-0 50090567400 1 TUBE in 1 CARTON (50090-5674-0) / 28 g in 1 TUBE 1 tube 2021-09-17 0000-00-00 No No Current