Home NDC 50268-503 miconazole nitrate
Product NDC 50268-503
11-digit product format 502680503
Labeler code 50268
Product ID 50268-503_47fa5320-5565-5626-e063-6394a90a4396
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form SOLUTION
Route TOPICAL
Labeler AvPAK
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-13
Substance MICONAZOLE NITRATE
Active strength 20 mg/mL
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/mL
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 998525 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 50268-503-29 miconazole nitrate 29.57 mL in 1 BOTTLE SOLUTION 29.57 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-503 MICONAZOLE NITRATE SOLUTION [AVPAK] 6 Current NDC, Legacy NDC, 1 package rows 20240308_eaf016f6-b631-af00-e053-2a95a90adc7b.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 50268-503-29 50268050329 29.57 mL in 1 BOTTLE (50268-503-29) 29.57 ml 2022-10-13 0000-00-00 No No Current