Home NDC 36800-754 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 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 TopCare Antifungal
Brand name suffix Maximum Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 25 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-754-01 TopCare AntifungalMaximum Strength 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-754 TOPCARE ANTIFUNGAL MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [TOPCO ASSOCIATES LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241107_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 8 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-754-01 36800075401 30 mL in 1 BOTTLE, WITH APPLICATOR (36800-754-01) 30 ml 2019-04-22 0000-00-00 No No Current