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 17 of 51 · 1,004 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fungicure Anti-Fungal Liquid TOLNAFTATE Kobayashi Healthcare International, Inc. b18ee199-0659-733c-e053-2a95a90ab6b5 2026-04-01 Warnings Exact identifier application number: M005 Tolnaftate ANTIFUNGAL LIQUID SPRAY CVS Pharmacy 96cc594d-85c8-4f62-bc0a-3176c8739f21 2026-04-01 Warnings Exact identifier application number: M005 Tolnafate TOLNAFTATE POWDER SPRAY CVS Pharmacy a7b6bd7c-23db-43e1-92f7-e27f5f4801de 2026-04-01 Warnings Exact identifier application number: M005 Baza Antifungal MICONAZOLE NITRATE Coloplast Corp 75182cb7-840a-423a-9c20-10840d6e1d65 2026-03-31 Warnings Exact identifier application number: M005 MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE Trifecta Pharmaceuticals Usa Llc 80217dbb-a0f0-414a-8d22-a9a346b017aa 2026-03-31 Warnings Exact identifier application number: M005 RoyceDerm Antifungal Bar CLOTRIMAZOLE RoyceDerm LLC 3abdc4a8-58dd-5bd0-e063-6294a90a1bca 2026-03-31 Warnings Exact identifier application number: M005 Critic Aid Clear AF MICONAZOLE NITRATE Coloplast Corp cbc5d976-850a-476e-b179-b7a5a8675524 2026-03-31 Warnings Exact identifier application number: M005 Velloryn ANTIFUNGAL Cream ZINC UNDECYLENATE, UNDECYLENIC ACID Guangdong Quadrant Ecological Technology Co., Ltd. 4e38e1f1-0466-5b91-e063-6294a90a66c4 2026-03-30 Warnings Exact identifier application number: M005 APUREE Nailtific Extra-Max Strength Daytime Antigungal APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL Guangzhou Meixi Biotechnology Co., Ltd. 4e3d226b-57f1-75a6-e063-6394a90a96cd 2026-03-30 Warnings Exact identifier application number: M005 APUREE Nailtific Extra-Max Strength Nighttime Antifungal APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL Guangzhou Meixi Biotechnology Co., Ltd. 4e3e8895-34b4-de69-e063-6294a90a5532 2026-03-30 Exact identifier application number: M005 Miconazole Nitrate ATHLETES FOOT POWDER SPRAY TALC FREE CVS Pharmacy 3380263d-ee7b-4946-a467-35a24789a901 2026-03-27 Warnings Exact identifier application number: M005 Micro-Guard (AF) MICONAZOLE NITRATE Coloplast Corp a43a94d0-fec0-470f-bdb4-535dcce6d1e0 2026-03-27 Warnings Exact identifier application number: M005 Suave Antibacterial Hand Wash Fresh Citrus LIQUID HAND WASH ANTIBACTERIAL Suave Brands Co, LLC 41d77ec6-a1d1-13dc-e063-6394a90a95f4 2026-03-26 Warnings Exact identifier application number: M005 Suave Antibacterial Hand Wash Deeply Clean LIQUID HAND WASH ANTIBACTERIAL Suave Brands Co, LLC 41d83736-66da-abb9-e063-6294a90a3d67 2026-03-26 Warnings Exact identifier application number: M005 Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera LIQUID HAND WASH ANTIBACTERIAL Suave Brands Co, LLC 41d8848c-d157-6e2c-e063-6294a90aa259 2026-03-26 Warnings Exact identifier application number: M005 Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch ANTIFUNGAL TREATMENT KIT Beautivity LLC 4800a93b-7042-827b-e063-6294a90acd95 2026-03-25 Warnings Exact identifier application number: M005 Toenail Fungus Treatment TERBINAFINE Shenzhen Wankelai E-commerce Co., Ltd. 4dc1d7f7-e4ae-c54b-e063-6394a90aa420 2026-03-24 Warnings Exact identifier application number: M005 Lasolex Liquid Solution CLOTRIMAZOLE 1% PureTek Corporation 4dc9e64d-8235-b218-e063-6394a90a0157 2026-03-24 Warnings Exact identifier application number: M005 Hermon Jock Itch Antifungal Treatment .Soap. Bar TOLNAFTATE 1% Beautivity LLC 4dbbf09b-5bc1-501b-e063-6394a90a2a9d 2026-03-23 Warnings Exact identifier application number: M005 Hermon Jock Itch Antifungal Treatment Cream MICONAZOLE NITRATE 2% Beautivity LLC 4dbc521c-2f5f-9736-e063-6294a90ad85d 2026-03-23 Warnings Exact identifier application number: M005
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