Home NDC 85636-021 Nail Repair Pen
Product NDC 85636-021
11-digit product format 856360021
Labeler code 85636
Product ID 85636-021_520f6c97-9697-e27a-e063-6394a90a51fc
Type HUMAN OTC DRUG
Nonproprietary name Nail Repair Pen
Dosage form LIQUID
Route TOPICAL
Labeler Shenzhen Earth Surface Trading Co., Ltd.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-05
Substance UNDECYLENIC ACID
Active strength 25 mg/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 Nail Repair Pen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 25 mg/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 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 85636-021-01 Nail Repair Pen 6 mL in 1 BOTTLE LIQUID 6 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 23 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85636-021-01 85636002101 6 mL in 1 BOTTLE (85636-021-01) 6 ml 2025-05-27 Yes No Current