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
IngredientStrength
TOLNAFTATE1 g/100mL
UNDECYLENIC ACID25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV, K3D86KJ24N
Rxcui2691548

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83766-108-01ERWCNMIE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51
83766-108-01ERWCNMIE Toenail Fungus Treatment Pen3 in 1 PACKAGELIQUID31
83766-108-02ERWCNMIE Toenail Fungus Treatment Pen6 in 1 PACKAGELIQUID61
83766-108-02ERWCNMIE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51
83766-108-03ERWCNMIE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51
83766-108-03ERWCNMIE Toenail Fungus Treatment Pen9 in 1 PACKAGELIQUID91

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN3dce0c33-d4f3-5135-e063-6394a90a85a61
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD3dce0c33-d4f3-5135-e063-6394a90a85a61
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY3dce0c33-d4f3-5135-e063-6394a90a85a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83766-108-01837660108013 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-01) / 5 mL in 1 BOTTLE, WITH APPLICATOR2025-09-02NoNoCurrent
83766-108-02837660108026 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-02) / 5 mL in 1 BOTTLE, WITH APPLICATOR2025-09-02NoNoCurrent
83766-108-03837660108039 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-108-03) / 5 mL in 1 BOTTLE, WITH APPLICATOR2025-09-02NoNoCurrent