FDA.reportPublic FDA data

Listerine Total Care Zero Alcohol Anticavity

Product NDC
69968-0194
11-digit product format
699680194
Labeler code
69968
Product ID
69968-0194_299c6a16-03d5-8332-e063-6394a90a6ab7
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-07-25
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-019469968-0194-2DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Listerine Total Care Zero Alcohol Anticavity
Brand name suffix
Fresh Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup
1798474Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b594a6e-db1d-443b-bfa7-23ee15749f47Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0194-1Listerine Total Care Zero Alcohol AnticavityFresh Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007
69968-0194-2Listerine Total Care Zero Alcohol AnticavityFresh Mint27 mL in 1 BOTTLE, PLASTICMOUTHWASH277
69968-0194-5Listerine Total Care Zero Alcohol AnticavityFresh Mint500 mL in 1 BOTTLE, PLASTICMOUTHWASH5007
69968-0194-9Listerine Total Care Zero Alcohol AnticavityFresh Mint95 mL in 1 BOTTLE, PLASTICMOUTHWASH957

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0194LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY FRESH MINT (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 4 package rows20241102_4b594a6e-db1d-443b-bfa7-23ee15749f47.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 51 · 1,019 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4b594a6e-db1d-443b-bfa7-23ee15749f477
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4b594a6e-db1d-443b-bfa7-23ee15749f477
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD4b594a6e-db1d-443b-bfa7-23ee15749f477
313029sodium fluoride 0.2 MG/ML MouthwashSCD4b594a6e-db1d-443b-bfa7-23ee15749f477
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4b594a6e-db1d-443b-bfa7-23ee15749f477
1798474Listerine 0.2 MG/ML MouthwashSY4b594a6e-db1d-443b-bfa7-23ee15749f477
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY4b594a6e-db1d-443b-bfa7-23ee15749f477
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4b594a6e-db1d-443b-bfa7-23ee15749f477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0194-1699680194011000 mL in 1 BOTTLE, PLASTIC (69968-0194-1) 1000 ml2012-07-250000-00-00NoNoCurrent
69968-0194-26996801940227 mL in 1 BOTTLE, PLASTIC (69968-0194-2) 27 ml2012-07-250000-00-00NoNoCurrent
69968-0194-569968019405500 mL in 1 BOTTLE, PLASTIC (69968-0194-5) 500 ml2012-07-250000-00-00NoNoCurrent
69968-0194-96996801940995 mL in 1 BOTTLE, PLASTIC (69968-0194-9) 95 ml2012-07-250000-00-00NoNoCurrent