Home NDC 83766-108 ERWCNMIE Toenail Fungus Treatment Pen
Product NDC 83766-108
11-digit product format 837660108
Labeler code 83766
Product ID 83766-108_3dce0c33-d4f4-5135-e063-6394a90a85a6
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate, UNDECYLENIC ACID
Dosage form LIQUID
Route TOPICAL
Labeler Shenzhen Joyuflsh Technology Co.,Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-02
Substance TOLNAFTATE; UNDECYLENIC ACID
Active strength 1; 25 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ERWCNMIE Toenail Fungus Treatment Pen
Listing expiration 2026-12-31 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 83766-108-01 ERWCNMIE Toenail Fungus Treatment Pen 5 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 5 1 83766-108-01 ERWCNMIE Toenail Fungus Treatment Pen 3 in 1 PACKAGE LIQUID 3 1 83766-108-02 ERWCNMIE Toenail Fungus Treatment Pen 6 in 1 PACKAGE LIQUID 6 1 83766-108-02 ERWCNMIE Toenail Fungus Treatment Pen 5 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 5 1 83766-108-03 ERWCNMIE Toenail Fungus Treatment Pen 5 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 5 1 83766-108-03 ERWCNMIE Toenail Fungus Treatment Pen 9 in 1 PACKAGE LIQUID 9 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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83766-108-01 83766010801 3 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-01) / 5 mL in 1 BOTTLE, WITH APPLICATOR 2025-09-02 No No Current 83766-108-02 83766010802 6 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-02) / 5 mL in 1 BOTTLE, WITH APPLICATOR 2025-09-02 No No Current 83766-108-03 83766010803 9 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-03) / 5 mL in 1 BOTTLE, WITH APPLICATOR 2025-09-02 No No Current