FDA.reportPublic FDA data

Listerine Smart Rinse Berry Splash

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:36:49

Label at a glance#

ProductListerine Smart 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 remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup. vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow...

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 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
  • remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • replace cap promptly after use
  • 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, 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). www.listerine.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!
2X STRONGER TEETH
FOR BETTER CAVITY PROTECTION*
ANTICAVITY FLUORIDE RINSE
LISTERINE ®
SMART RiNSE ®
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
ALCOHOL FREE

*Versus brushing alone,
In a lab study.
IMPORTANT: Read
directions for proper use.

ADA
Accepted
American
Dental
Association ®

BERRY
SLASH
500 mL (16.9 fl oz)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN6
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN6
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD6
313029sodium fluoride 0.2 MG/ML MouthwashSCD6
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY6
1798474Listerine 0.2 MG/ML MouthwashSY6
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY6
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY6

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
69968-0606-3Listerine Smart Rinse Berry Splash27 mL in 1 BOTTLE, DISPENSINGMOUTHWASH276
69968-0606-5Listerine Smart Rinse Berry Splash500 mL in 1 BOTTLE, DISPENSINGMOUTHWASH5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0606LISTERINE SMART RINSE BERRY SPLASH (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 2 package rows20241114_5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b.zip

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
69968-060669968-0606-5, 69968-0606-3

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
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
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 Smart Rinse Berry SplashSODIUM FLUORIDEKenvue Brands LLC5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b2024-11-11WarningsExact identifier
ndc (package): 69968-0606-5
ndc (package): 69968-0606-3
ndc (product): 69968-0606
ndc11 (package): 69968060605
ndc11 (package): 69968060603
spl id: 21be25b1-b487-3c76-e063-6394a90ac748
spl set id: 5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b

Reported adverse events (FAERS/openFDA)#

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