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 41 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 1236-CS Antifungal Powder (Talc Free) 1236-CCANTIFUNGAL POWDER(TALC FREE) Dynarex Corporation 312ba573-4008-83e6-e063-6294a90a4a6d 2025-03-25 Warnings Exact identifier application number: M005 Antifungal Medicated Bar TOLNAFTATE RoyceDerm LLC 31305ed2-a0a0-6d4c-e063-6294a90a6ba5 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antimicrobial Hydrogel Wound Dressing BENZETHONIUM CHLORIDE, THYMOL Lidan, Inc cd5b7a72-1b87-434d-973e-071d2c8a438c 2025-03-25 Warnings Exact identifier application number: M005 Forticept HP Antiseptic Wound Cleanser BENZALKONIUM CHLORIDE, ALLANTOIN Lidan, inc. 41bb46ee-edce-4e1b-bcfd-5c5729e1eb15 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Gel CLOTRIMAZOLE Lidan, Inc. 1b5851fc-ae73-4e54-bb62-3ff928628b97 2025-03-25 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Preferred Pharmaceuticals Inc. 14d2a661-a490-41ca-b84f-f2be3bc271b4 2025-03-24 Warnings Exact identifier application number: M005 Dermatin Antifungal CLOTRIMAZOLE Melaleuca, Inc. e993fa3b-1d85-46b7-bda5-ed875be74c4e 2025-03-20 Warnings Exact identifier application number: M005 1% ketoconazole KETOCONAZOLE TAGRID LLC 30b75584-3a1e-c125-e063-6294a90acaa7 2025-03-19 Warnings Exact identifier application number: M005 Forticept Antifungal Foot Cream CLOTRIMAZOLE Lidan, Inc. 17abeb4d-b211-4b8c-a9d2-4c7baba2450c 2025-03-07 Warnings Exact identifier application number: M005 Terramed Just Think Comfort Antifungal Medicated Body Wipes TOLNAFTATE Rida LLC 34577389-8e5d-49ab-a208-9c87b6f3cec4 2025-03-06 Warnings Exact identifier application number: M005 Athletes Foot MICONAZOLE NITRATE Rida LLC 85e98ef8-75c3-4be1-b59f-40b5312e2137 2025-03-06 Warnings Exact identifier application number: M005 SOUTH BEACH MULTI-PURPOSE NAIL REPAIR UNDECYLENIC ACID SOUTH BEACH HAIR CARE PROFESIONAL INC 2fb0110c-b275-2a17-e063-6394a90a2d30 2025-03-06 Warnings Exact identifier application number: M005 DG Health Athletes Foot CLOTRIMAZOLE Dolgencorp, Inc. 20370b32-21ad-4362-9b46-c6149c907231 2025-02-28 Warnings Exact identifier application number: M005 Family Wellness Clotrimazole 1 Anti Fungal Cream CLOTRIMAZOLE Family Dollar Stores, Inc 0667dd81-5633-494e-857e-45fa276fe72c 2025-02-25 Warnings Exact identifier application number: M005 Family Wellness Athletes Foot Tolnaftate 1 Cream TOLNAFTATE Family Dollar Stores, Inc f72b5bcd-8834-4da9-aa74-78992ec2838f 2025-02-25 Warnings Exact identifier application number: M005 ANTIFUNGAL MEDICATED BODY WASH TOLNAFTATE Rida LLC e3ebce6f-88ca-4100-ac79-d300f44e4891 2025-02-25 Warnings Exact identifier application number: M005 FUNGINIX AF TOLNAFTATE The Sisquoc Healthcare Corporation f6cf5315-6678-486c-85b2-d4b3f748600e 2025-02-25 Warnings Exact identifier application number: M005 FUNGINIX JOCK ITCH TREATMENT TOLNAFTATE The Sisquoc Healthcare Corporation b2ce1c25-93d5-441f-9b3b-68ae46400c2c 2025-02-25 Warnings Exact identifier application number: M005 Miconazole Nitrate MICONAZOLE NITRATE A-S Medication Solutions bf131f33-3ab2-4f43-add5-920e78ac36a7 2025-02-24 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Preferred Pharmaceuticals Inc. 0052992a-819c-4c55-bd88-201a09a3573a 2025-02-21 Warnings Exact identifier application number: M005
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