Listerine

Basic Information

• Brand Name: Listerine
• Primary DI: 00312547202282
• Version / Model: 00312547202282
• Company Name: Kenvue Brands LLC
• Labeler DUNS: 118772437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-01
• Public Version: 1
• Public Version Date: 2025-01-09
• Public Version Status: New
• Public Device Record Key: 63c180c2-ebae-43ca-afca-9865891b1541

Device Description

LISTERINE CLINICAL SOLUTIONS SENSITIVE TEETH 500ML

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	VARNISH, CAVITY	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64795	Dental coating, tooth-desensitizing, home-use	A material available for use by a patient/layperson outside a clinical setting designed to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, strips); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00312547202282	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143155	000