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
Ingredient	Strength
UNDECYLENIC ACID	25 g/100mL
TOLNAFTATE	1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K3D86KJ24N	Internal UNII lookup
06KB629TKV	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3dcdb0c4-e0ec-dfee-e063-6294a90a0bda	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83766-107-01	DRAWZONE Toenail Fungus Treatment Pen	5 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	5		3
83766-107-01	DRAWZONE Toenail Fungus Treatment Pen	6 in 1 PACKAGE	LIQUID	6		3

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DRAWZONE Toenail Fungus Treatment Pen	TOLNAFTATE, UNDECYLENIC ACID	Shenzhen Joyuflsh Technology Co.,Ltd.	3dcdb0c4-e0ec-dfee-e063-6294a90a0bda	2025-09-05	Warnings	Exact identifier ndc (product): 83766-107

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE
K3D86KJ24N	UNDECYLENIC ACID	112-38-9	UNDECYLENIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2691548	tolnaftate 1 % / undecylenic acid 25 % Topical Solution	PSN	3dcdb0c4-e0ec-dfee-e063-6294a90a0bda	3
2691548	tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical Solution	SCD	3dcdb0c4-e0ec-dfee-e063-6294a90a0bda	3
2691548	tolnaftate 1 % / undecylenic acid 25 % Topical Solution	SY	3dcdb0c4-e0ec-dfee-e063-6294a90a0bda	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83766-107-01	83766010701	6 BOTTLE, WITH APPLICATOR in 1 PACKAGE (83766-107-01) / 5 mL in 1 BOTTLE, WITH APPLICATOR	2025-09-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
83766-107 DRAWZONE Toenail Fungus Treatment Pen	Shenzhen Joyuflsh Technology Co.,Ltd.	2025-09-05	HUMAN OTC DRUG LABEL	3