FDA.reportPublic FDA data

Listerine

Primary DI
00312547235969
Brand
Listerine
Company
Kenvue Brands LLC
Model
00312547235969
Device description
LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 250 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
00312547235969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00312547235969003125472359693125472359690312547235969

GMDN Terms#

Term, Definition table
TermDefinition
Dental mouthwashA liquid solution in the form of a mouthwash intended for the cleansing and disinfecting of the oral cavity for the protection and health of the teeth and gums by restricting bacterial development. Some formulations may provide specific benefits for the teeth (e.g., fluoride, whitening agents). It is normally available [non-prescription] over-the-counter (OTC) for use in hospitals, institutions or for home use. 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
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
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
20827854027120Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
20827854027571Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
07615208299373Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10
07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839943M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840073M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840143M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840213M™ Clinpro™3M COMPANYLBH2023-12-14
10810111542873FluoroCalBISCO INC.LBH2023-12-11
10810111542897FluoroCalBISCO INC.LBH2023-12-11
10371347011590Advance Dental ProductsThe Atlanta Dental Supply CompanyLBH2023-11-29
10732224005550Sparkle V Sodium Fluoride Varnish, CherryCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005567Sparkle V Sodium Fluoride Varnish, CaramelCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005574Sparkle V Sodium Fluoride Varnish, MelonCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
10732224000319Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02