Home NDC 53329-256-64 Medline
Product NDC 53329-256
Requested package NDC 53329-256-64
11-digit product format 533290256
Labeler code 53329
Product ID 53329-256_509fcf56-d5a6-6adb-e063-6394a90a0be4
Type HUMAN OTC DRUG
Nonproprietary name Miconazole nitrate
Dosage form OINTMENT
Route TOPICAL
Labeler Medline Industries, LP
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-05
Substance MICONAZOLE NITRATE
Active strength 20 mg/g
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 Medline
Listing expiration 2027-12-31 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 998442 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 967 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53329-256-64 53329025664 142 g in 1 TUBE (53329-256-64) 142 g 2026-08-05 No No Current