FDA.reportPublic FDA data

Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash

Manufacturer
Kenvue Brands LLC
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:30

Label at a glance#

ProductListerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash
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 ...

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 a 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, Flavor, Phosphoric Acid, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 33, Green 3

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 - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

ADA
Accepted

American

Dental

Association ®

24-HR CAVITY

PROTECTION †

†when used twice daily

kid-approved taste

ANTICAVITY FLUORIDE RINSE

LISTERINE®

TOTAL CARE KiDS

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

6IN1

BENEFITS*

BERRY

SPLASH

KID-APPROVED

TASTE

500mL(16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

69968-090469968-0904

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN2
313029sodium fluoride 0.2 MG/ML MouthwashSCD2
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY2
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312547115810GTIN-13: 0312547115810
EAN-13: 0312547115810
GTIN-12: 312547115810
UPC-A: 312547115810
GTIN storage (14 digits): 00312547115810		69968-0904.jpg
Data codeData Matrix3005825769968-0904.jpg
Data codeData Matrix3005825869968-0904.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0904-3Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash27 mL in 1 BOTTLEMOUTHWASH272
69968-0904-5Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash500 mL in 1 BOTTLEMOUTHWASH5002

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-090469968-0904-5, 69968-0904-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
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 Kids Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLC28986d7f-3e9a-8dfb-e063-6394a90a731e2025-12-10WarningsExact identifier
ndc (package): 69968-0904-5
ndc (package): 69968-0904-3
ndc (product): 69968-0904
ndc11 (package): 69968090405
ndc11 (package): 69968090403
spl id: 4599a1af-50b0-9a26-e063-6294a90ad25d
spl set id: 28986d7f-3e9a-8dfb-e063-6394a90a731e

Reported adverse events (FAERS/openFDA)#

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