Home NDC 84387-003 MICONAZOLE NITRATE
Product NDC 84387-003
11-digit product format 843870003
Labeler code 84387
Product ID 84387-003_26bc78a5-3755-5f69-e063-6394a90a11a8
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form OINTMENT
Route TOPICAL
Labeler ALLIED TRADE LINK LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-25
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 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 84387-003-01 MICONAZOLE NITRATE 28.4 g in 1 TUBE OINTMENT 28.4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84387-003 MICONAZOLE NITRATE OINTMENT [ALLIED TRADE LINK LLC] 2 Current NDC, 1 package rows 20241115_25520dba-0159-2a3f-e063-6294a90a4c33.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84387-003-01 84387000301 28.4 g in 1 TUBE (84387-003-01) 28.4 g 2024-10-25 No No Current