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

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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui313029, 1798474

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

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