Home NDC 58980-819 AZOLEN
Product NDC 58980-819
11-digit product format 589800819
Labeler code 58980
Product ID 58980-819_85b974c1-bef2-4320-93a4-0fcf7774c55c
Type HUMAN OTC DRUG
Nonproprietary name MICONAZOLE NITRATE
Dosage form LIQUID
Route TOPICAL
Labeler STRATUS PHARMACEUTICALS INC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-14
Substance MICONAZOLE NITRATE
Active strength 2 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 AZOLEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2 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 58980-819-60 AZOLEN 170 g in 1 BOTTLE LIQUID 170 2 58980-819-60 AZOLEN 1 in 1 BOX LIQUID 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-819 AZOLEN (MICONAZOLE NITRATE) LIQUID [STRATUS PHARMACEUTICALS INC] 2 Current NDC, 2 package rows 20241102_3264bd0a-c628-404b-8c09-8586682d054e.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 36 of 49 · 969 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58980-819-60 58980081960 1 BOTTLE in 1 BOX (58980-819-60) / 170 g in 1 BOTTLE 1 bottle 2023-09-14 No No Current