FDA.reportPublic FDA data

Listerine

Primary DI
00312547235952
Brand
Listerine
Company
Kenvue Brands LLC
Model
00312547235952
Device description
LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 95 ML
Published
2017-12-10
Public version status
Update
Distribution status
Not 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
00312547235952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00312547235952003125472359523125472359520312547235952

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and 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, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00False

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
00312547202282Listerine003125472022822025-01-01
00312547202299Listerine003125472022992025-01-01
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