Home NDC 85569-017 Treatonic Antifungal Pen
Product NDC 85569-017
11-digit product format 855690017
Labeler code 85569
Product ID 85569-017_55b69f19-20f6-4203-e063-6394a90a43b0
Type HUMAN OTC DRUG
Nonproprietary name 25% Undecylenic Acid
Dosage form GEL
Route TOPICAL
Labeler 100 KARMA INC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-18
Substance UNDECYLENIC ACID
Active strength 2.25 g/9g
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 Treatonic Antifungal Pen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 2.25 g/9g
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 1362039 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 36 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85569-017-01 85569001701 3 BOTTLE, DROPPER in 1 CARTON (85569-017-01) / 3 g in 1 BOTTLE, DROPPER 2026-06-18 No No Current