DRAWZONE Toenail Fungus Treatment Pen

Product NDC
83766-107
11-digit product format
837660107
Labeler code
83766
Product ID
83766-107_3e0b2e1c-f893-f214-e063-6394a90a3ff7
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
DRAWZONE 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
83766-107-01DRAWZONE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID53
83766-107-01DRAWZONE Toenail Fungus Treatment Pen6 in 1 PACKAGELIQUID63

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN3dcdb0c4-e0ec-dfee-e063-6294a90a0bda3
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD3dcdb0c4-e0ec-dfee-e063-6294a90a0bda3
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY3dcdb0c4-e0ec-dfee-e063-6294a90a0bda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83766-107-01837660107016 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-107-01) / 5 mL in 1 BOTTLE, WITH APPLICATOR2025-09-02NoNoCurrent