TopCare Antifungal

Product NDC
36800-754
11-digit product format
368000754
Labeler code
36800
Product ID
36800-754_f35e1f5c-9f88-44d9-8496-b302551ed482
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-22
Substance
UNDECYLENIC ACID
Active strength
25 mg/30mL
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
TopCare Antifungal
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c44fb4e-0eef-4ced-b03f-a02ebe6c0264Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-754-01TopCare AntifungalMaximum Strength30 mL in 1 BOTTLE, WITH APPLICATORLIQUID307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-754TOPCARE ANTIFUNGAL MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 1 package rows20241107_7c44fb4e-0eef-4ced-b03f-a02ebe6c0264.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 24 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FortiniaCLOTRIMAZOLEThe Podiatree Company60ba6f8a-8617-d4f6-e053-2991aa0a4a712026-01-08WarningsExact identifier
application number: M005
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
application number: M005
Wet wipesWET WIPESShenzhen Shierjie Biological Engineering Co., LTD273b3ae2-6dec-31a4-e063-6294a90aca892026-01-07WarningsExact identifier
application number: M005
Bee Venom Fungal Nail Treatment LiquidBEE VENOM FUNGAL NAIL TREATMENTShenzhen Earth Surface Trading Co., Ltd.47c37468-ba5c-0d11-e063-6294a90ac5542026-01-06WarningsExact identifier
application number: M005
ProBliva Anti Fungal Shampoo.ANTIFUNGALCAVTECH HOLDING LLC47af9ff8-5d5c-4524-e063-6394a90ac91f2026-01-05WarningsExact identifier
application number: M005
Beauty Creations Pink Halo Hand Sanitizer MistETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.dda9f4cb-e431-4164-be61-0daf1a86d10f2026-01-04WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.477c971d-829f-5040-e063-6394a90a41e42026-01-03WarningsExact identifier
application number: M005
Nail Renovar PlusTOLNAFTATESOHM, Inc2c09925c-e63e-4d9b-8d76-b06bd2cba26c2026-01-02WarningsExact identifier
application number: M005
Natural Sense Full Body Cleansing TowelCLEANSING TOWELDr. Natural LLC4742eec4-b7a3-2c89-e063-6294a90a19fc2025-12-31WarningsExact identifier
application number: M005
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
application number: M005
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
application number: M005
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
application number: M005
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
application number: M005
CuraNails Antifungal PenUNDECYLENIC ACID 25%Quality Discount Inc.3e641d36-72f6-4682-bd31-f7cd04d857f22025-12-25WarningsExact identifier
application number: M005
Opti-Nail 2-in-1TOLNAFTATEKramer Laboratoriesbc8a5492-8bd0-4c80-a270-e4958aeb5ed62025-12-23WarningsExact identifier
application number: M005
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
application number: M005
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-754-013680007540130 mL in 1 BOTTLE, WITH APPLICATOR (36800-754-01) 30 ml2019-04-220000-00-00NoNoCurrent