FDA.reportPublic FDA data

Biotene Oral Rinse Dry Mouth

Primary DI
00048582004405
Brand
Biotene Oral Rinse Dry Mouth
Company
Haleon US Holdings LLC
Model
1
Device description
Biotene Oral Rinse Dry Mouth 33.8 oz.
Published
2023-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LFDSaliva, Artificial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFDSaliva, ArtificialUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123731000BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYGlaxosmithkline Consumer Healthcare (Gskch)2013-01-04LFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00048582004405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00048582004405000485820044050485820044050048582004405

GMDN Terms#

Term, Definition table
TermDefinition
Artificial salivaAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079944263
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00307663076091EroxonEight Pack2025-04-01
00307663075896EroxonEight Pack2025-04-01
00307663074806EroxonFour Pack2024-09-26
00048582003309BioteneDry Mouth Oral Rinse2023-04-14
00048582004566BioteneDry Mouth Gentle Oral Rinse2023-04-14
00048582004580BioteneDry Mouth Gentle Oral Rinse2023-04-14
00048582100077BioteneDry Mouth Sample2023-04-14
00048582120266BioteneEcommerce Variety Pack Rinse Spray2023-04-14
00048582285422BioteneOral Rinse Twin Pack2023-04-14
00048582350410BioteneOral Rinse Twin Pack2023-04-14
00048582802209BioteneOral Rinse Dry Mouth2023-04-14
00048582001558BioteneMouth Spray2023-04-14
00048582512016BioteneOral Balance Gel2023-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809334440016MucoPEG™SunBio, Inc.LFD2026-06-01
00350930098029Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00350930098081Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00858290006987Allday Oral Moisturizing Rinse, 10oz BottleELEVATE ORAL CARE, LLCLFD2026-05-01
00810051089004GuruNandaGurunanda, LLCLFD2026-01-28
00810051089479GuruNandaGurunanda, LLCLFD2026-01-28
00647692000132CloSYS Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.LFD2025-12-16
00899655002220SaliveaLACLEDE, INC.LFD2025-06-16
00697366003556SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00697366003570SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00850058655086Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655055Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655109Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
05060146293129Caphosol® Artifical SalivaEUSA PHARMA (UK) LIMITEDLFD2024-06-26
08426181972769Xerostom® Saliva Substitute GelBIO COSMETICS SLLFD2024-04-01
05060146291576CaphosolEUSA PHARMA (UK) LIMITEDLFD2024-03-27
00304369600421Moi-stir 4 oz w/ sprayerCentury Pharmaceuticals IncLFD2024-02-14
00370275629047SalivaMAXForward Science Technologies LLCLFD2024-02-14
D132DMS0020CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
D132DMS0030MeijerOralabs, LLCLFD2024-01-29
00050428446102CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
00708820384446MeijerOralabs, LLCLFD2024-01-29
00858290006895Povi-OneELEVATE ORAL CARE, LLCLFD2023-09-27
00899655002213SaliveaLACLEDE, INC.LFD2023-09-22
00899655002251Salivea LACLEDE, INC.LFD2023-09-12
00899655002275SaliveaLACLEDE, INC.LFD2023-09-12
D132DMS0010CVS Dry Mouth SprayOralabs, LLCLFD2023-08-14
00858290006871Allday Spray/Gel Sample BagELEVATE ORAL CARE, LLCLFD2023-05-18
00048582001558BioteneHaleon US Holdings LLCLFD2023-04-14
00048582003309BioteneHaleon US Holdings LLCLFD2023-04-14