FDA.reportPublic FDA data

Listerine Clinical Solutions Teeth Strength Alpine Mint

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:36:45

Label at a glance#

ProductListerine Clinical Solutions Teeth Strength Alpine Mint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Indications and uses

aids in the prevention of dental cavities

Dosage and administration

Adults and children 12 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 supervise children as necessary until capable of using without supervision Children under 12 years of age: consult a dentist or a doctor

Storage and handling

store at room temperature cold weather may 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

Uses

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 12 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
  • supervise children as necessary until capable of using without supervision

Children under 12 years of age: consult a dentist or a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol, Sorbitol, Poloxamer 407, Flavor, Sodium Lauryl Sulfate, Eucalyptol, Sodium Saccharin, Methyl Salicylate, Thymol, Phosphoric Acid, Menthol, Sucralose, Disodium Phosphate, Green 3, Yellow 10

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 - 1 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE®

CLINICAL

SOLUTIONS

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

TEETH STRENGTH

Repairs enamel now to prevent cavities

for 3X stronger* and longer-lasting teeth

(*with brushing in a lab study)

ALPINE MINT

1L (1 Qt 1.8 Fl Oz)

Listerine_01Listerine_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN3
313029sodium fluoride 0.2 MG/ML MouthwashSCD3
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY3
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
69968-0819-1Listerine Clinical Solutions Teeth Strength Alpine Mint1000 mL in 1 BOTTLEMOUTHWASH10003
69968-0819-5Listerine Clinical Solutions Teeth Strength Alpine Mint500 mL in 1 BOTTLEMOUTHWASH5003
69968-0819-9Listerine Clinical Solutions Teeth Strength Alpine Mint95 mL in 1 BOTTLEMOUTHWASH953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0819LISTERINE CLINICAL SOLUTIONS TEETH STRENGTH ALPINE MINT (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]3Current NDC, 3 package rows20241114_06e2de03-4a58-3de0-e063-6294a90a5857.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-081969968-0819-9, 69968-0819-5, 69968-0819-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM LAURYL SULFATE368GB5141JIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
EUCALYPTOLRV6J6604TKIACT
MENTHOLL7T10EIP3AIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
THYMOL3J50XA376EIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

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 Clinical Solutions Teeth Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC06e2de03-4a58-3de0-e063-6294a90a58572024-11-11WarningsExact identifier
ndc (package): 69968-0819-9
ndc (package): 69968-0819-5
ndc (package): 69968-0819-1
ndc (product): 69968-0819
ndc11 (package): 69968081909
ndc11 (package): 69968081905
ndc11 (package): 69968081901
spl id: 223b617c-b851-5b58-e063-6394a90a57b0
spl set id: 06e2de03-4a58-3de0-e063-6294a90a5857

Reported adverse events (FAERS/openFDA)#

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