Home NDC 85578-003 TEGASOLVE TOENAIL FUNGUS TREATMENT
Product NDC 85578-003
11-digit product format 855780003
Labeler code 85578
Product ID 85578-003_375b0515-1b20-23b8-e063-6294a90a9d68
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid 25%
Dosage form LIQUID
Route TOPICAL
Labeler Zhengzhou Hangrui Network Technology Co., Ltd.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-12
Substance UNDECYLENIC ACID
Active strength 25 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 TEGASOLVE TOENAIL FUNGUS TREATMENT
Listing expiration 2026-12-31 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 85578-003-01 TEGASOLVE TOENAIL FUNGUS TREATMENT 30 mL in 1 BOTTLE LIQUID 30 1 85578-003-01 TEGASOLVE TOENAIL FUNGUS TREATMENT 1 in 1 BOX LIQUID 1 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 85578-003-01 85578000301 1 BOTTLE in 1 BOX (85578-003-01) / 30 mL in 1 BOTTLE 1 bottle 2025-06-12 No No Current