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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact 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