Home NDC 85038-001 Toenail Fungus Treatment Extra Strength Pen
Product NDC 85038-001
11-digit product format 850380001
Labeler code 85038
Product ID 85038-001_4e77e84f-737b-3e6b-e063-6394a90a3bbc
Type HUMAN OTC DRUG
Nonproprietary name TOLNAFTATE, UNDECYLENIC ACID
Dosage form LIQUID
Route TOPICAL
Labeler Lianjiang Shanlilai E-commerce Co., Ltd.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-11
Substance TOLNAFTATE; UNDECYLENIC ACID
Active strength 1; 25 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 Toenail Fungus Treatment Extra Strength Pen
Listing expiration 2027-12-31 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85038-001-01 Toenail Fungus Treatment Extra Strength Pen 3 in 1 PACKAGE LIQUID 3 2 85038-001-01 Toenail Fungus Treatment Extra Strength Pen 5 mL in 1 BOTTLE LIQUID 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85038-001 TOENAIL FUNGUS TREATMENT EXTRA STRENGTH PEN (TOLNAFTATE, UNDECYLENIC ACID) LIQUID [LIANJIANG SHANLILAI E-COMMERCE CO., LTD.] 1 Current NDC, 2 package rows 20241213_28fbcc50-a3ac-d6d1-e063-6294a90aa2b6.zip
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 85038-001-01 85038000101 3 BOTTLE in 1 PACKAGE (85038-001-01) / 5 mL in 1 BOTTLE 3 bottle 2024-12-11 No No Current