FDA.reportPublic FDA data

ORAL-B DRY MOUTH RINSE

Primary DI
00068305100221
Brand
ORAL-B DRY MOUTH RINSE
Company
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Model
N/A
Device description
Dry Mouth Oral Rinse
Published
2022-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFDSaliva, Artificial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFDSaliva, ArtificialUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00068305100221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00068305100221000683051002210683051002210068305100221

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

Contacts#

Phone, Email table
PhoneEmail
1-800-566-7252xxx@xx.xx

Regulatory Flags#

DUNS number
004238200
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00073010720091TampaxTampax Radiant Regular, Radiant Pocket Regular, Pe2026-06-25
00073010720831TampaxTampax Pearl Super, Regular, Triple Pak - Super, R2026-06-25
00073010721173TampaxTampax Pearl Super, Super Plus, Ultra2026-06-25
00073010721210This is LThis is L Organic Regular, Super2026-06-25
00073010721227TampaxTampax Pearl Regular, Super2026-06-25
00073010721272TampaxTampax Pearl Triple Pak - Super, Super Plus, Ultra2026-06-25
00073010721333This is LThis is L Organic Super, Super Plus2026-06-25
00073010721340TampaxTampax Pearl Super, Regular PDQ2026-06-25
00073010721517This is LThis is L Organic Super, Super plus2026-06-25
00073010721524This is LThis is L Organic Triple Pak - Regular, Super, Sup2026-06-25
00073010721616This is LThis is L Organic Regular, Super2026-06-25
00073010721623This is LThis is L Organic Regular, Super2026-06-25
00073010721685TampaxTampax Pearl Super, Regular, Super Plus PDQ2026-06-25
00073010721807TampaxTampax Pearl Super, Regular Floorstand2026-06-25
00073010721845TampaxTampax Radiant Sidecap2026-06-25
00073010721906TampaxTampax Pearl Super, Regular Pallet2026-06-25
00073010721968TampaxTampax Pearl Super, Regular, Compact Floorstand2026-06-25
00047400703117Braun Silk.expert Pro 5PL51002026-01-05
00047400703230Braun Silk.expert Pro 5PL54422026-01-05
00047400703360Braun Skin i-expertPL72192026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083135027BioXtraORABIO, INC.LFD2026-06-23
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