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

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 Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309370, 1045620

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

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