FDA.reportPublic FDA data

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
IngredientStrength
MICONAZOLE NITRATE2 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3264bd0a-c628-404b-8c09-8586682d054eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-819-60AZOLEN170 g in 1 BOTTLELIQUID1702
58980-819-60AZOLEN1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-819AZOLEN (MICONAZOLE NITRATE) LIQUID [STRATUS PHARMACEUTICALS INC]2Current NDC, 2 package rows20241102_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 22 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Select Advanced Hand SanitizerALCOHOLLiving Better Brands LLC6d1cc25b-d612-4aae-bdb0-304758ef8f0f2026-01-26WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEPadagis Israel Pharmaceuticals Ltd3dcd0158-ec51-4fa7-a26a-02c2926156c02026-01-22WarningsExact identifier
application number: M005
Puriya Antifungal BalmZINC UNDECYLENATEIPC Republic, Inc.96bf44bc-b5eb-4198-9056-02e51665a1622026-01-22WarningsExact identifier
application number: M005
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
application number: M005
LIGHTS SwabstickBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.9346512e-53a1-420a-8b4d-bfbec32576a22026-01-21WarningsExact identifier
application number: M005
Lights Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4905a27c-6cf8-4b1a-a02c-4c81756e8c0a2026-01-21WarningsExact identifier
application number: M005
Bee Venom Fungal Nail Treatment LiquidBEE VENOM FUNGAL NAIL TREATMENTShenzhen Earth Surface Trading Co., Ltd.48d164bc-dab6-6fe4-e063-6394a90a3fc42026-01-20WarningsExact identifier
application number: M005
TolnaftateMEIJER ATHLETES FOOT LIQUID SPRAYMeijer Distribution Inc.d9f7753f-aef9-86e2-e053-2995a90a20822026-01-20WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYMeijer Distribution Incb3ba676e-9377-4665-b99e-d4143df96b362026-01-20WarningsExact identifier
application number: M005
TolnaftateMEIJER ATHLETES FOOT LIQUIDMeijer Distribution Inc.0399dfef-9ea6-6fe4-e063-6394a90aec432026-01-20WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH LiquidTOLNAFTATEShenzhen Ctrip Technology Co., Ltd.1fb03184-5f21-c82a-e063-6294a90a9fa42026-01-19WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEAvKARE1a26534d-eeb8-8d17-e063-6294a90a70c72026-01-19WarningsExact identifier
application number: M005
Hermon Antifungal Soap. 4 packsTOLNAFTATE 1%Beautivity LLC42c769de-f1e1-b3a1-e063-6394a90ab2a12026-01-18WarningsExact identifier
application number: M005
Hermon Antifungal Cleansing BarTOLNAFTATE 1%Beautivity LLC48b5d7b3-a134-ecdd-e063-6294a90a32132026-01-18WarningsExact identifier
application number: M005
ANTIFUNGAL TOENAIL FUNGUS PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd48b5fbd9-bdf5-21ac-e063-6394a90aa6b62026-01-18WarningsExact identifier
application number: M005
Hermon Antifungal Soap.TOLNAFTATE 1%Beautivity LLC41e37014-549c-e592-e063-6294a90ac6ab2026-01-17WarningsExact identifier
application number: M005
Hermon Antifungal .soap.TOLNAFTATE 1%Beautivity LLC482c338f-870f-f6d7-e063-6394a90a432c2026-01-17WarningsExact identifier
application number: M005
MEOLY Fungal Nail RenewalFUNGAL NAIL RENEWALShenzhen Xinxin Yunhai Technology Co., Ltd.487d2e22-6328-893f-e063-6394a90a9dff2026-01-16WarningsExact identifier
application number: M005
Lotrimin AntifungalMICONAZOLE NITRATEBayer HealthCare LLC.cebd222c-074f-443c-bd37-612114b27bbd2026-01-16WarningsExact identifier
application number: M005
Lotrimin Daily PreventionTOLNAFTATEBayer HealthCare LLC.9e8f9211-e85d-725a-e053-2995a90a09b32026-01-16WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58980-819-60589800819601 BOTTLE in 1 BOX (58980-819-60) / 170 g in 1 BOTTLE1 bottle2023-09-14NoNoCurrent