FDA.reportPublic FDA data

Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash

Manufacturer
Kenvue Brands LLC
Effective date
2026-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:11

Label at a glance#

ProductListerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

Adults and children 6 years of age and older: use twice daily 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 u...

Storage and handling

store at room temperature

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

Warnings

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 daily 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

POWERED BY ESSENTIAL OILS + FLUROIDE

6

IN 1

FOR A HEALTHIER MOUTH

360

CLEAN*

FRESHENS

BREATH

KILLS 99.9%

OF GERMS*

REPAIRS

ENAMEL

24 HR CAVITY

PROTECTION †

STRENGTHENS

TEETH

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

1.0 L (1 Qt 1.8 FL Oz)

ListerineListerine

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312547202589GTIN-13: 0312547202589
EAN-13: 0312547202589
GTIN-12: 312547202589
UPC-A: 312547202589
GTIN storage (14 digits): 00312547202589		Listerine-1.jpg
QR code linkQR Code2d.kenvue.com/01/00312547202589Listerine-1.jpg
Data codeData Matrix30061778Listerine-1.jpg
Data codeData Matrix30061780Listerine-1.jpg
Data codeData Matrix30062550Listerine-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0950-1Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash1000 mL in 1 BOTTLEMOUTHWASH10001
69968-0950-2Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash250 mL in 1 BOTTLEMOUTHWASH2501
69968-0950-5Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash500 mL in 1 BOTTLEMOUTHWASH5001

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-095069968-0950-1, 69968-0950-5, 69968-0950-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
EUCALYPTOLRV6J6604TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
PHOSPHORIC ACIDE4GA8884NNIACT
METHYL SALICYLATELAV5U5022YIACT
THYMOL3J50XA376EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
MENTHOLL7T10EIP3AIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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 Extra Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d1932f-a85c-7b8f-e063-6394a90a6aca2026-02-02WarningsExact identifier
ndc (package): 69968-0950-5
ndc (package): 69968-0950-1
ndc (package): 69968-0950-2
ndc (product): 69968-0950
ndc11 (package): 69968095002
ndc11 (package): 69968095001
ndc11 (package): 69968095005
spl id: 49d1932f-a85d-7b8f-e063-6394a90a6aca
spl set id: 49d1932f-a85c-7b8f-e063-6394a90a6aca

Reported adverse events (FAERS/openFDA)#

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