Fungicure LiquidGel

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:51:40

Label at a glance#

ProductFungicure LiquidGel
Active ingredientUNDECYLENIC ACID
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAFungicureLiquidGelPDPCAFungicureLiquidGelPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1362041FungiCURE Maximum Strength 25 % Topical GelPSN9
1362039undecylenic acid 25 % Topical GelPSN9
1362041undecylenic acid 0.25 MG/MG Topical Gel [FungiCure Maximum Strength]SBD9
1362039undecylenic acid 0.25 MG/MG Topical GelSCD9
1362041FungiCure Maximum Strength 0.25 MG/MG Topical GelSY9
1362041FungiCure Maximum Strength 25 % Topical GelSY9
1362039undecylenic acid 25 % Topical GelSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-633-09Fungicure LiquidGel1 in 1 BOXGEL19
52389-633-09Fungicure LiquidGel9 g in 1 TUBE, WITH APPLICATORGEL99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-633FUNGICURE LIQUIDGEL (UNDECYLENIC ACID) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]9Legacy NDC, 2 package rows20250110_ee5b4f26-0ed7-4e33-931e-8a31afa0cd9a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Undecylenic acidACTIVE INGREDIENTK3D86KJ24N1
Undecylenic acidACTIVE MOIETYK3D86KJ24N1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
Aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P1
Isopropyl alcoholINACTIVE INGREDIENTND2M4163021
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-63352389-633-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, COATED PELLETS / ORAL41.4 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PLOTION / TOPICAL6 mgExact identifier — unii candidate
27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, CHEWABLE / ORAL10 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PFILM, EXTENDED RELEASE / TRANSDERMAL19 mgExact identifier — unii candidate
27 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, DELAYED RELEASE / ORAL450 mgExact identifier — unii candidate
27 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TOPICAL222 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGRANULE, FOR SUSPENSION / ORAL194 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PPOWDER, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PLOZENGE / ORAL500 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL39.2 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, EXTENDED RELEASE / ORAL864 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED, EXTENDED RELEASE / ORAL187.6 mgExact identifier — unii candidate
27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE / ORAL120 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PSUSPENSION / ORAL100 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TRANSDERMAL20 mgExact identifier — unii candidate
27 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, DELAYED RELEASE / ORAL150 mgExact identifier — unii candidate
27 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PLOTION, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PFILM / BUCCAL87 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, EXTENDED RELEASE / ORAL204 mgExact identifier — unii candidate
27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGRANULE / ORAL13 mgExact identifier — unii candidate
27 equally ranked IID candidates
Isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PSOLUTION / TOPICAL200 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PPOWDER / ORAL244 mgExact identifier — unii candidate
27 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b36a73d-a794-ff2a-e063-6294a90a6ff8ee5b4f26-0ed7-4e33-931e-8a31afa0cd9a2025-01-08Exact identifier
spl id: 2b36a73d-a794-ff2a-e063-6294a90a6ff8
spl set id: ee5b4f26-0ed7-4e33-931e-8a31afa0cd9a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.