FDA.reportPublic FDA data

Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint

Manufacturer
Kenvue Brands LLC
Effective date
2025-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:26

Label at a glance#

ProductListerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse. do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of...

Storage and handling

store at room temperature cold weather may temporarily cloud this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride (0.02%) (0.01% w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older:
    • use twice a day after brushing your teeth with a toothpaste.
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse.
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • cold weather may temporarily cloud this product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, Disodium Phosphate, Sucralose, Red 40, Blue 1

Questions?

OTC - QUESTIONS SECTION

call toll-free 888-222-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

24-HR CAVITY PROTECTION †

& KILLS 99.9% OF GERMS*

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

MILD TASTE

6 IN 1

BENEFITS

1. 24-HOUR CAVITY PROTECTION †

2. RESTORES ENAMEL

3. STRENGTHENS TEETH

4. FRESHENS BREATH

5. CLEANS WHOLE MOUTH

6. KILLS BAD BREATH GERMS

†when used twice daily *bad breath germs

FRESH MINT

1.0 L (1 Qt 1.8 Fl Oz)

Listerine_1Listerine_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1
1798474Listerine 0.2 MG/ML MouthwashSY1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-092469968-0924-1, 69968-0924-5, 69968-0924-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 407TUF2IVW3M2IACT
EUCALYPTOLRV6J6604TKIACT
METHYL SALICYLATELAV5U5022YIACT
THYMOL3J50XA376EIACT
PHOSPHORIC ACIDE4GA8884NNIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
ndc (package): 69968-0924-5
ndc (package): 69968-0924-9
ndc (package): 69968-0924-1
ndc (product): 69968-0924
ndc11 (package): 69968092401
ndc11 (package): 69968092405
ndc11 (package): 69968092409
spl id: 346daec1-8785-c736-e063-6394a90ab3c6
spl set id: 346daeae-7590-176c-e063-6294a90a52ea

Reported adverse events (FAERS/openFDA)#

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