Home NDC 42291-938 Miconazole Nitrate
Product NDC 42291-938
11-digit product format 422910938
Labeler code 42291
Product ID 42291-938_48c0e508-e6c0-3d43-e063-6294a90a3ade
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form POWDER
Route TOPICAL
Labeler AvKARE
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-05
Substance MICONAZOLE NITRATE
Active strength 2 g/100g
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 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 998461 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 42291-938-85 Miconazole Nitrate 85 g in 1 BOTTLE POWDER 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-938 MICONAZOLE NITRATE POWDER [AVKARE] 1 Current NDC, 1 package rows 20240615_1a26534d-eeb8-8d17-e063-6294a90a70c7.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 42291-938-85 42291093885 85 g in 1 BOTTLE (42291-938-85) 85 g 2024-06-05 No No Current