Home NDC 87259-001 SFEIXE ANTIFUNGAL PEN
Product NDC 87259-001
11-digit product format 872590001
Labeler code 87259
Product ID 87259-001_4aadaa12-6087-45e0-e063-6394a90a3af1
Type HUMAN OTC DRUG
Nonproprietary name UNDECYLENIC ACID
Dosage form PASTE
Route TOPICAL
Labeler Zhejiang JOOZENA Medical Technology Co., Ltd.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-08
Substance UNDECYLENIC ACID
Active strength 25 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 SFEIXE ANTIFUNGAL PEN
Listing expiration 2027-12-31 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 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 87259-001-01 SFEIXE ANTIFUNGAL PEN 6 mL in 1 TUBE PASTE 6 2 87259-001-01 SFEIXE ANTIFUNGAL PEN 3 in 1 BOX PASTE 3 2
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 12 of 13 · 242 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87259-001-01 87259000101 3 TUBE in 1 BOX (87259-001-01) / 6 mL in 1 TUBE 3 tube 2025-12-08 No No Current