Home NDC 85966-013 Extra Strength Toenail Renewal Solution
Product NDC 85966-013
11-digit product format 859660013
Labeler code 85966
Product ID 85966-013_4eed68e6-6815-0181-e063-6394a90a888e
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid, Tolnaftate
Dosage form SOLUTION
Route TOPICAL
Labeler GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-08
Substance UNDECYLENIC ACID; TOLNAFTATE
Active strength .25; .01 g/mL; g/mL
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 Extra Strength Toenail Renewal Solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID .25 g/mL TOLNAFTATE .01 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup 06KB629TKV 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 85966-013-01 Extra Strength Toenail Renewal Solution 30 mL in 1 BOTTLE SOLUTION 30 1 85966-013-02 Extra Strength Toenail Renewal Solution 5 mL in 1 BOTTLE, DROPPER SOLUTION 5 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 85966-013-01 85966001301 30 mL in 1 BOTTLE (85966-013-01) 30 ml 2026-04-08 No No Current 85966-013-02 85966001302 5 mL in 1 BOTTLE, DROPPER (85966-013-02) 5 ml 2026-04-08 No No Current