Home NDC 85248-217 HTRCSW FUNGAL NAIL RENEWAL
Product NDC 85248-217
11-digit product format 852480217
Labeler code 85248
Product ID 85248-217_571cb0b6-61fc-d9f7-e063-6294a90a0fe4
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid 25% TOENAIL FUNGUS PEN
Dosage form LIQUID
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-20
Substance UNDECYLENIC ACID; TOLNAFTATE
Active strength 25; 1 g/100mL; 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 HTRCSW FUNGAL NAIL RENEWAL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 25 g/100mL TOLNAFTATE 1 g/100mL
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85248-217-01 HTRCSW FUNGAL NAIL RENEWAL 3 in 1 BOX LIQUID 3 1 85248-217-01 HTRCSW FUNGAL NAIL RENEWAL 5 mL in 1 TUBE LIQUID 5 1 85248-217-02 HTRCSW FUNGAL NAIL RENEWAL 10 mL in 1 TUBE LIQUID 10 1 85248-217-02 HTRCSW FUNGAL NAIL RENEWAL 2 in 1 BOX LIQUID 2 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 36 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 85248-217-01 85248021701 3 TUBE in 1 BOX (85248-217-01) / 5 mL in 1 TUBE 3 tube 2026-05-20 No No Current 85248-217-02 85248021702 2 TUBE in 1 BOX (85248-217-02) / 10 mL in 1 TUBE 2 tube 2026-05-20 No No Current