Fungicure Liquid Gel

Product NDC
52389-733
11-digit product format
523890733
Labeler code
52389
Product ID
52389-733_41ae836c-6a1d-e223-e063-6394a90ae05a
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
GEL
Route
TOPICAL
Labeler
Kobayashi Healthcare International, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-31
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fungicure Liquid Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui1049535

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-733-09Fungicure Liquid Gel1 in 1 BOXGEL19
52389-733-09Fungicure Liquid Gel9 g in 1 TUBE, WITH APPLICATORGEL99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-733FUNGICURE LIQUID GEL (CLOTRIMAZOLE) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]8Current NDC, Legacy NDC, 2 package rows20240509_dfd03852-29bd-4e16-97f3-64dfde5f8ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049535clotrimazole 1 % Topical GelPSNdfd03852-29bd-4e16-97f3-64dfde5f8ff89
1049535clotrimazole 0.01 MG/MG Topical GelSCDdfd03852-29bd-4e16-97f3-64dfde5f8ff89
1049535clotrimazole 1 % Topical GelSYdfd03852-29bd-4e16-97f3-64dfde5f8ff89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52389-733-09523890733091 TUBE, WITH APPLICATOR in 1 BOX (52389-733-09) / 9 g in 1 TUBE, WITH APPLICATOR2016-01-040000-00-00NoNoCurrent