Biotene

Basic Information

• Brand Name: Biotene
• Primary DI: 00048582004580
• Version / Model: Dry Mouth Gentle Oral Rinse
• Company Name: Haleon US Holdings LLC
• Labeler DUNS: 079944263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-14
• Public Version: 2
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: 766edd17-9a90-45dc-86d3-6826207c5581

Device Description

Biotene Dry Mouth Gentle Oral Rinse 33.8 oz

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFD	Saliva, Artificial	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
37576	Artificial saliva	An electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. 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	00048582004580	GS1

Premarket Submissions

Submission Number	Supplement Number
K123731	000