Home NDC 58980-818 Azolen
Product NDC 58980-818
11-digit product format 589800818
Labeler code 58980
Product ID 58980-818_0892f504-c8a8-4aff-9901-223635b876c2
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form TINCTURE
Route TOPICAL
Labeler Stratus Pharmaceuticals, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-09-15
Substance MICONAZOLE NITRATE
Active strength 20 mg/mL
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 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 58980-818-10 Azolen 29.57 mL in 1 BOTTLE, WITH APPLICATOR TINCTURE 29.57 4 58980-818-10 Azolen 1 in 1 BOX TINCTURE 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Miconazole Nitrate ACTIVE INGREDIENT VW4H1CYW1K AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Miconazole ACTIVE MOIETY 7NNO0D7S5M AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Acetic Acid INACTIVE INGREDIENT Q40Q9N063P AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Isopropyl Alcohol INACTIVE INGREDIENT ND2M416302 AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Laureth-4 INACTIVE INGREDIENT 6HQ855798J AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-818 AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20171024_9c2574f3-3be4-405a-9c87-943dc6ef8777.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 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58980-818-10 58980081810 1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR 2017-09-15 0000-00-00 No No Current