FDA.reportPublic FDA data

Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:36:55

Label at a glance#

ProductListerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast
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 u...

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, Flavor, Phosphoric Acid, Sucralose, Cetylpyridinium Chloride, Disodium Phosphate, Sodium Saccharin, Menthol, Blue , Green 3

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2X STRONGER TEETH FOR

BETTER CAVITY PROTECTION*

*with brushing, in a lab study

ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE

LISTERINE ®

SMART RiNSE ®

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

BUBBLE

BLAST

500 mL (16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

Bubble BlastBubble Blast

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBD4
313029sodium fluoride 0.2 MG/ML MouthwashSCD4
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4
1798474Listerine 0.2 MG/ML MouthwashSY4
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY4
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4

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
69968-0690-5Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast500 mL in 1 BOTTLEMOUTHWASH5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0690LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BUBBLE BLAST (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 1 package rows20241114_f09f334b-709c-473e-b91e-3f31480ceb90.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-069069968-0690-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SUCRALOSE96K6UQ3ZD4IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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 Anticavity Fluoride Rinse - Bubble BlastSODIUM FLUORIDEKenvue Brands LLCf09f334b-709c-473e-b91e-3f31480ceb902024-11-11WarningsExact identifier
ndc (package): 69968-0690-5
ndc (product): 69968-0690
ndc11 (package): 69968069005
spl id: 22c63b22-afc1-daa3-e063-6394a90a2ef9
spl set id: f09f334b-709c-473e-b91e-3f31480ceb90

Reported adverse events (FAERS/openFDA)#

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