Home NDC 85210-001 Antifungal Pen
Product NDC 85210-001
11-digit product format 852100001
Labeler code 85210
Product ID 85210-001_9e2dd8ab-e1b8-43fd-b156-f3788c591db4
Type HUMAN OTC DRUG
Nonproprietary name UNDECYLENIC ACID 25%
Dosage form LIQUID
Route TOPICAL
Labeler XF Agencija Limited
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-28
Substance UNDECYLENIC ACID
Active strength 25 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998329 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 85210-001-01 Antifungal Pen 1 in 1 CARTON LIQUID 1 1 85210-001-01 Antifungal Pen 3 mL in 1 APPLICATOR LIQUID 3 1 85210-001-02 Antifungal Pen 3 mL in 1 APPLICATOR LIQUID 3 1 85210-001-02 Antifungal Pen 3 in 1 CARTON LIQUID 3 1 85210-001-03 Antifungal Pen 6 in 1 CARTON LIQUID 6 1 85210-001-03 Antifungal Pen 3 mL in 1 APPLICATOR LIQUID 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85210-001 ANTIFUNGAL PEN (UNDECYLENIC ACID 25%) LIQUID [XF AGENCIJA LIMITED] 1 Current NDC, 6 package rows 20250129_a15d4512-0fc6-424f-9dd3-ab433d9b7a26.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 23 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 85210-001-01 85210000101 1 APPLICATOR in 1 CARTON (85210-001-01) / 3 mL in 1 APPLICATOR 1 applicator 2025-01-28 No No Current 85210-001-02 85210000102 3 APPLICATOR in 1 CARTON (85210-001-02) / 3 mL in 1 APPLICATOR 3 applicator 2025-01-28 No No Current 85210-001-03 85210000103 6 APPLICATOR in 1 CARTON (85210-001-03) / 3 mL in 1 APPLICATOR 6 applicator 2025-01-28 No No Current