SEFUDUN NAIL FUNGUS TREATMENT

Product NDC: 83804-002
11-digit product format: 838040002
Labeler code: 83804
Product ID: 83804-002_34ab96b8-aed9-14da-e063-6294a90a5667
Type: HUMAN OTC DRUG
Nonproprietary name: Zingiber Officinale (Ginger) Root Extract
Dosage form: LIQUID
Route: TOPICAL
Labeler: Shenzhen Shandian Jingling Technology Co., Ltd.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-05-09
Substance: GINGER
Active strength: 30 g/60mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
GINGER	30 g/60mL

Field, Values table
Field	Values
Unii	C5529G5JPQ

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83804-002-01	SEFUDUN NAIL FUNGUS TREATMENT	60 mL in 1 BOTTLE	LIQUID	60		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83804-002	SEFUDUN NAIL FUNGUS TREATMENT (ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT) LIQUID [SHENZHEN SHANDIAN JINGLING TECHNOLOGY CO., LTD.]	1	Current NDC, 1 package rows	20250510_34ab96b8-aed8-14da-e063-6294a90a5667.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
C5529G5JPQ	GINGER	GINGER

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83804-002-01	83804000201	60 mL in 1 BOTTLE (83804-002-01)	60 ml	2025-05-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
83804-002 SEFUDUN NAIL FUNGUS TREATMENT	Shenzhen Shandian Jingling Technology Co., Ltd.	2025-05-08	HUMAN OTC DRUG LABEL	1