FDA.reportPublic FDA data

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 15 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWal-Mart Stores, Incaf4ebb3b-041e-30dd-e053-2995a90a8d2d2026-04-22WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYWal-Mart Stores, Incaf4dd045-ca51-42b9-e053-2a95a90a03272026-04-22WarningsExact identifier
application number: M005
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC4fc3ddc8-08a2-ae50-e063-6294a90a1e072026-04-18WarningsExact identifier
application number: M005
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
application number: M005
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsExact identifier
application number: M005
Ingrown Nail TreatmentJALAWEF INGROWN NAIL TREATMENTConsilii LLC1ac2d7fc-1806-7925-e063-6294a90ad3b52026-04-15WarningsExact identifier
application number: M005
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
application number: M005
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
application number: M005
OSIMOON Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4f7817db-cd71-fba9-e063-6294a90a9cdf2026-04-14WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL PERSIMMONTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f520058-3b81-574e-e063-6294a90a2eae2026-04-13WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL CHARCOALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f538041-e2f1-4a5f-e063-6294a90a54cf2026-04-13WarningsExact identifier
application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
application number: M005
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact 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