Home NDC 85966-001 Extra Strength Nail Fungus Treatment
Product NDC 85966-001
11-digit product format 859660001
Labeler code 85966
Product ID 85966-001_3dced015-71fd-f6ab-e063-6294a90a0dc3
Type HUMAN OTC DRUG
Nonproprietary name UNDECYLENIC ACID, TOLNAFTATE
Dosage form LIQUID
Route TOPICAL
Labeler GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-25
Substance TOLNAFTATE; UNDECYLENIC ACID
Active strength 1; 25 g/100mL; g/100mL
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 Extra Strength Nail Fungus Treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100mL UNDECYLENIC ACID 25 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup 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 2691548 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85966-001-01 Extra Strength Nail Fungus Treatment 30 mL in 1 BOTTLE LIQUID 30 3 85966-001-02 Extra Strength Nail Fungus Treatment 30 mL in 1 BOTTLE LIQUID 30 3 85966-001-02 Extra Strength Nail Fungus Treatment 2 in 1 BOX LIQUID 2 3
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 85966-001-01 85966000101 30 mL in 1 BOTTLE (85966-001-01) 30 ml 2025-07-25 No No Current 85966-001-02 85966000102 2 BOTTLE in 1 BOX (85966-001-02) / 30 mL in 1 BOTTLE 2 bottle 2025-07-25 No No Current