FDA.reportPublic FDA data

Listerine Total Care Fresh Mint Anticavity Fluoride

Product NDC
69968-0787
11-digit product format
699680787
Labeler code
69968
Product ID
69968-0787_2f34589b-07a1-9fef-e063-6394a90a851a
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
2023-01-13
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 Fresh Mint Anticavity Fluoride
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
ed15e0b9-00c9-0df1-e053-2a95a90a42c0Available 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
69968-0787-1Listerine Total Care Fresh Mint Anticavity Fluoride1000 mL in 1 BOTTLEMOUTHWASH10006
69968-0787-2Listerine Total Care Fresh Mint Anticavity Fluoride95 mL in 1 BOTTLEMOUTHWASH956
69968-0787-3Listerine Total Care Fresh Mint Anticavity Fluoride3 in 1 PACKAGEMOUTHWASH36
69968-0787-3Listerine Total Care Fresh Mint Anticavity Fluoride1000 mL in 1 BOTTLEMOUTHWASH10006
69968-0787-4Listerine Total Care Fresh Mint Anticavity Fluoride1000 mL in 1 BOTTLEMOUTHWASH10006
69968-0787-4Listerine Total Care Fresh Mint Anticavity Fluoride2 in 1 PACKAGEMOUTHWASH26
69968-0787-5Listerine Total Care Fresh Mint Anticavity Fluoride500 mL in 1 BOTTLEMOUTHWASH5006
69968-0787-6Listerine Total Care Fresh Mint Anticavity Fluoride250 mL in 1 BOTTLEMOUTHWASH2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0787LISTERINE TOTAL CARE FRESH MINT ANTICAVITY FLUORIDE (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 8 package rows20250303_ed15e0b9-00c9-0df1-e053-2a95a90a42c0.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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Cavity Protection Great Regular FlavorANTICAVITY FLUORIDE TOOTHPASTEColgate-Palmolive Company202c6c62-e16a-4716-babe-d5414006c79e2026-01-21WarningsExact identifier
application number: M021
Crest 3D White Luxe Diamond StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc1420129-5460-4900-ac9a-356d2d7c60a22026-01-21WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsExact identifier
application number: M021
Colgate Total Gum Protect WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companydcf81dcb-b26b-4411-82d4-5f7e9d3fc0f32026-01-20WarningsExact identifier
application number: M021
GuruNanda Anti-CavitySODIUM FLUORIDEGURUNANDA, LLC3b07b72f-4efc-eb0f-e063-6294a90a70a82026-01-19WarningsExact identifier
application number: M021
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
application number: M021
HismilePEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0eba92d1-cbdc-9c96-e063-6294a90a9afc2026-01-15WarningsExact identifier
application number: M021
HismileCOCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3cfb6-6bae-1682-e063-6394a90aca882026-01-15WarningsExact identifier
application number: M021
HismileMANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3f4f8-fdc4-2056-e063-6394a90a6fd72026-01-15WarningsExact identifier
application number: M021
HismileSMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef41051-dfa0-b105-e063-6294a90a551f2026-01-15WarningsExact identifier
application number: M021
HismileWATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef43107-58ec-d4ee-e063-6294a90ad8d72026-01-15WarningsExact identifier
application number: M021
HismileRED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef56539-dc21-c6ea-e063-6394a90a57902026-01-15WarningsExact identifier
application number: M021
HismileGRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef6f8b5-8565-b364-e063-6294a90aabbc2026-01-15WarningsExact identifier
application number: M021
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNed15e0b9-00c9-0df1-e053-2a95a90a42c06
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNed15e0b9-00c9-0df1-e053-2a95a90a42c06
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBDed15e0b9-00c9-0df1-e053-2a95a90a42c06
313029sodium fluoride 0.2 MG/ML MouthwashSCDed15e0b9-00c9-0df1-e053-2a95a90a42c06
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSYed15e0b9-00c9-0df1-e053-2a95a90a42c06
1798474Listerine 0.2 MG/ML MouthwashSYed15e0b9-00c9-0df1-e053-2a95a90a42c06
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYed15e0b9-00c9-0df1-e053-2a95a90a42c06
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYed15e0b9-00c9-0df1-e053-2a95a90a42c06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0787-1699680787011000 mL in 1 BOTTLE (69968-0787-1) 1000 ml2023-01-130000-00-00NoNoCurrent
69968-0787-26996807870295 mL in 1 BOTTLE (69968-0787-2) 95 ml2023-01-130000-00-00NoNoCurrent
69968-0787-3699680787033 BOTTLE in 1 PACKAGE (69968-0787-3) / 1000 mL in 1 BOTTLE3 bottle2023-01-13NoNoCurrent
69968-0787-4699680787042 BOTTLE in 1 PACKAGE (69968-0787-4) / 1000 mL in 1 BOTTLE2 bottle2023-01-13NoNoCurrent
69968-0787-569968078705500 mL in 1 BOTTLE (69968-0787-5) 500 ml2023-01-130000-00-00NoNoCurrent
69968-0787-669968078706250 mL in 1 BOTTLE (69968-0787-6) 250 ml2025-01-01NoNoCurrent