Home NDC 85248-204 Kakalsa TOENAIL FUNGUS TREATMENT
Product NDC 85248-204
11-digit product format 852480204
Labeler code 85248
Product ID 85248-204_5716c502-8465-c29e-e063-6394a90a963b
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid 25% TOENAIL FUNGUS TREATMENT
Dosage form LIQUID
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-06
Substance UNDECYLENIC ACID
Active strength 25 g/100mL
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 Kakalsa TOENAIL FUNGUS TREATMENT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 25 g/100mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998329 Internal RxNorm 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 85248-204-01 Kakalsa TOENAIL FUNGUS TREATMENT 3 mL in 1 TUBE LIQUID 3 1 85248-204-01 Kakalsa TOENAIL FUNGUS TREATMENT 4 in 1 BOX LIQUID 4 1 85248-204-02 Kakalsa TOENAIL FUNGUS TREATMENT 56 mL in 1 BOTTLE LIQUID 56 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85248-204-01 85248020401 4 TUBE in 1 BOX (85248-204-01) / 3 mL in 1 TUBE 4 tube 2026-05-06 No No Current 85248-204-02 85248020402 56 mL in 1 BOTTLE (85248-204-02) 56 ml 2026-05-06 No No Current