Home NDC 53329-147 Medline
Product NDC 53329-147
11-digit product format 533290147
Labeler code 53329
Product ID 53329-147_5afac954-49e5-98fb-e063-6394a90ab6aa
Type HUMAN OTC DRUG
Nonproprietary name miconazole nitrate
Dosage form CREAM
Route TOPICAL
Labeler Medline Industries, LP
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-01
Marketing end 2027-09-01
Substance MICONAZOLE NITRATE
Active strength 20 mg/mL
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 Medline 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 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 53329-147-44 Medline 118 mL in 1 TUBE CREAM 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-147 MEDLINE (MICONAZOLE NITRATE) CREAM [MEDLINE INDUSTRIES, LP] 1 Current NDC, 1 package rows 20231230_0d997d1d-8663-201f-e063-6394a90a285e.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 51 · 1,004 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 53329-147-44 53329014744 118 mL in 1 TUBE (53329-147-44) 118 ml 2023-08-01 2027-09-01 No No Historical