FDA.reportPublic FDA data

Listerine

Primary DI
00312547202282
Brand
Listerine
Company
Kenvue Brands LLC
Model
00312547202282
Device description
LISTERINE CLINICAL SOLUTIONS SENSITIVE TEETH 500ML
Published
2025-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVARNISH, CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143155000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143155000LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp2015-01-29LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00312547202282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00312547202282003125472022823125472022820312547202282

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizing, home-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)361-8068xxx@xxx.com

Regulatory Flags#

DUNS number
118772437
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300450141019ZYRTEC003004501410192026-05-29
00300450141026ZYRTEC003004501410262026-05-29
00312547202299Listerine003125472022992025-01-01
00312547235952Listerine003125472359522017-12-10
00312547235976Listerine003125472359762017-12-10
00381372020453Johnson & Johnson First Aid003813720204532022-01-31
00381372020118Johnson & Johnson First Aid003813720201182021-08-16
00381372020682Johnson & Johnson Red Cross003813720206822021-07-30
00381371192533BAND-AID Brand Adhesive Bandages003813711925332021-02-01
00381371194827Johnson & Johnson First Aid003813711948272020-04-06
00070501101247Neutrogena000705011012472016-09-30
00070501101261Neutrogena000705011012612016-09-30
00070501101315Neutrogena000705011013152017-07-08
00070501260364Neutrogena000705012603642017-08-11
00070501260395Neutrogena000705012603952017-08-11
00070501302743Neutrogena000705013027432017-08-11
00074300012537Visine000743000125372016-09-05
00312547235969Listerine003125472359692017-12-10
00381370055679BAND-AID Brand Adhesive Bandages003813700556792018-09-12
00381370055709BAND-AID Brand Adhesive Bandages003813700557092018-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006606740Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606757Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606788Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00197998150340Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150371Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150401Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150432Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150463Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150494Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150517Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219092Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219108Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219115Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219139Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219146Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219214Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998486050Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
E22122751VOCO Profluorid Varnish + BioMinVOCO GmbHLBH2026-07-26
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10