FDA.reportPublic FDA data

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
IngredientStrength
MICONAZOLE NITRATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998525Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c2574f3-3be4-405a-9c87-943dc6ef8777Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-818-10Azolen29.57 mL in 1 BOTTLE, WITH APPLICATORTINCTURE29.574
58980-818-10Azolen1 in 1 BOXTINCTURE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-818-10ML - Milliliter58980-8185725ebf8-1f7d-4134-bb0d-aa43535c4da212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
MiconazoleACTIVE MOIETY7NNO0D7S5MAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
Acetic AcidINACTIVE INGREDIENTQ40Q9N063PAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
Laureth-4INACTIVE INGREDIENT6HQ855798JAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RAZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-818AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20171024_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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998525miconazole nitrate 2 % Topical SolutionPSN9c2574f3-3be4-405a-9c87-943dc6ef87774
998525miconazole nitrate 20 MG/ML Topical SolutionSCD9c2574f3-3be4-405a-9c87-943dc6ef87774
998525miconazole nitrate 2 % Topical SolutionSY9c2574f3-3be4-405a-9c87-943dc6ef87774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58980-818-10589800818101 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR2017-09-150000-00-00NoNoCurrent