FDA.reportPublic FDA data

Fungicure

Product NDC
52389-600
11-digit product format
523890600
Labeler code
52389
Product ID
52389-600_51def52b-eaf3-ed93-e063-6294a90ac924
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
LIQUID
Route
TOPICAL
Labeler
Kobayashi Healthcare International, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-06-05
Substance
CLOTRIMAZOLE
Active strength
10 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Fungicure
Brand name suffix
Intensive
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309370Internal RxNorm lookup
1045620Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f1b413f-278e-434f-8590-4cf731663f5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-600-60FungicureIntensive1 in 1 BOXLIQUID112
52389-600-60FungicureIntensive60 mL in 1 BOTTLE, SPRAYLIQUID6012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [ALVA-AMCO PHARMACAL COMPANIES, INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [ALVA-AMCO PHARMACAL COMPANIES, INC.]1
Isopropyl alcoholINACTIVE INGREDIENTND2M416302FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [ALVA-AMCO PHARMACAL COMPANIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-600FUNGICURE INTENSIVE (CLOTRIMAZOLE) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]10Current NDC, Legacy NDC, 2 package rows20241101_1f1b413f-278e-434f-8590-4cf731663f5c.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 46 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsb63a3fe5-5684-41bc-ad6c-69c54e5b942d2024-06-20WarningsExact identifier
application number: M005
THERA Antifungal BodyMICONAZOLE NITRATEMcKesson Medical-Surgical Inc.31096041-28c9-4b16-bbd1-dbadefd375052024-06-14WarningsExact identifier
application number: M005
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
application number: M005
Secura ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
application number: M005
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
application number: M005
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
application number: M005
CANESPIESTOLNAFTATEOPMX LLCe2f9eedc-3c43-416b-85b5-ba07fb5fb4db2024-05-17WarningsExact identifier
application number: M005
Up and Up AntifungalTOLNAFTATE 1%Target Corporation8f54c8c7-6771-49c3-b429-53aa6df54dc52024-05-08WarningsExact identifier
application number: M005
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
application number: M005
ADI Medical PVP-I Pouch, FoilPOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0e8baf24-0c67-5511-e063-6394a90acaa12024-05-02WarningsExact identifier
application number: M005
Caseys Antimicrobial Hand SanitizerETHYL ALCOHOLNavajo Manufacturing Company Inc.78863024-390c-4ff9-8ed6-02af07902a302024-04-29WarningsExact identifier
application number: M005
MQUPIN Liquid Fungal Nail TreatmentLIQUID FUNGAL NAIL TREATMENTZhengzhou Miaoqi Medical Technology Co., Ltd.14782f8c-3b29-1d88-e063-6294a90ac3e42024-03-25WarningsExact identifier
application number: M005
ETADERM Advanced Antifungal SupportUNDECYLENIC ACIDNUEPHASE LLCadb12a1c-ece9-4a59-a62c-89d212c57e6f2024-03-13WarningsExact identifier
application number: M005
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsExact identifier
application number: M005
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
application number: M005
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN1f1b413f-278e-434f-8590-4cf731663f5c12
1045620FungiCURE 1 % Topical SolutionPSN1f1b413f-278e-434f-8590-4cf731663f5c12
1045620clotrimazole 10 MG/ML Topical Solution [Fungicure Solution]SBD1f1b413f-278e-434f-8590-4cf731663f5c12
309370clotrimazole 10 MG/ML Topical SolutionSCD1f1b413f-278e-434f-8590-4cf731663f5c12
309370clotrimazole 1 % Topical SolutionSY1f1b413f-278e-434f-8590-4cf731663f5c12
1045620Fungicure 1 % Topical SolutionSY1f1b413f-278e-434f-8590-4cf731663f5c12
1045620Fungicure Solution 10 MG/ML Topical SolutionSY1f1b413f-278e-434f-8590-4cf731663f5c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52389-600-60523890600601 BOTTLE, SPRAY in 1 BOX (52389-600-60) / 60 mL in 1 BOTTLE, SPRAY2008-06-050000-00-00NoNoCurrent