FDA.reportPublic FDA data

Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint

Product NDC
69968-0924
11-digit product format
699680924
Labeler code
69968
Product ID
69968-0924_346daec1-8785-c736-e063-6394a90ab3c6
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
2025-03-02
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Alcohol Free Anticavity Fluoride Mouthwash 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
346daeae-7590-176c-e063-6294a90a52eaAvailable 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
69968-0924-1Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10001
69968-0924-5Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint500 mL in 1 BOTTLE, PLASTICMOUTHWASH5001
69968-0924-9Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint95 mL in 1 BOTTLE, PLASTICMOUTHWASH951

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0924LISTERINE TOTAL CARE ALCOHOL FREE ANTICAVITY FLUORIDE MOUTHWASH FRESH MINT (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]1Current NDC, 3 package rows20250507_346daeae-7590-176c-e063-6294a90a52ea.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 16 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Crest Complete plus Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960e0e3e-10e8-7426-e053-2a95a90a5b022026-02-12WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e2026-02-12WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN346daeae-7590-176c-e063-6294a90a52ea1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN346daeae-7590-176c-e063-6294a90a52ea1
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD346daeae-7590-176c-e063-6294a90a52ea1
313029sodium fluoride 0.2 MG/ML MouthwashSCD346daeae-7590-176c-e063-6294a90a52ea1
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY346daeae-7590-176c-e063-6294a90a52ea1
1798474Listerine 0.2 MG/ML MouthwashSY346daeae-7590-176c-e063-6294a90a52ea1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY346daeae-7590-176c-e063-6294a90a52ea1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY346daeae-7590-176c-e063-6294a90a52ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0924-1699680924011000 mL in 1 BOTTLE, PLASTIC (69968-0924-1) 1000 ml2025-03-02NoNoCurrent
69968-0924-569968092405500 mL in 1 BOTTLE, PLASTIC (69968-0924-5) 500 ml2025-03-02NoNoCurrent
69968-0924-96996809240995 mL in 1 BOTTLE, PLASTIC (69968-0924-9) 95 ml2025-03-02NoNoCurrent