Home NDC 87571-001 ANTIFUNGAL PEN
Product NDC 87571-001
11-digit product format 875710001
Labeler code 87571
Product ID 87571-001_4e85f338-ffd8-85b1-e063-6294a90a3c87
Type HUMAN OTC DRUG
Nonproprietary name UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Hanyang Qisheng (Shenzhen) Technology Co., Ltd.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-03
Substance TERBINAFINE HYDROCHLORIDE; UNDECYLENIC ACID
Active strength 1; 25 g/100mL; g/100mL
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [CS]
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 ANTIFUNGAL PEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBINAFINE HYDROCHLORIDE 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 012C11ZU6G 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 2740011 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 87571-001-01 ANTIFUNGAL PEN 5 mL in 1 BOTTLE LIQUID 5 1 87571-001-01 ANTIFUNGAL PEN 3 in 1 PACKAGE LIQUID 3 1 87571-001-02 ANTIFUNGAL PEN 6 in 1 PACKAGE LIQUID 6 1 87571-001-02 ANTIFUNGAL PEN 5 mL in 1 BOTTLE LIQUID 5 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 41 of 49 · 969 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 87571-001-01 87571000101 3 BOTTLE in 1 PACKAGE (87571-001-01) / 5 mL in 1 BOTTLE 3 bottle 2026-04-03 No No Current 87571-001-02 87571000102 6 BOTTLE in 1 PACKAGE (87571-001-02) / 5 mL in 1 BOTTLE 6 bottle 2026-04-03 No No Current