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

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 Liquid Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049535Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfd03852-29bd-4e16-97f3-64dfde5f8ff8Available 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
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

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

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