Home NDC 85569-005 TOENAIL FUNGUS TREATMENT
Product NDC 85569-005
11-digit product format 855690005
Labeler code 85569
Product ID 85569-005_55b676ed-e1d8-1700-e063-6394a90a6ec3
Type HUMAN OTC DRUG
Nonproprietary name 25% Undecylenic Acid
Dosage form LIQUID
Route TOPICAL
Labeler 100 KARMA INC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-31
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 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 85569-005-01 TOENAIL FUNGUS TREATMENT 30 mL in 1 CARTON LIQUID 30 2
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 51 · 1,004 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 85569-005-01 85569000501 30 mL in 1 CARTON (85569-005-01) 30 ml 2025-08-31 No No Current