Listerine Cool Mint Antiseptic

Manufacturer
Kenvue Brands LLC
Effective date
2025-03-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:56:45

Label at a glance#

ProductListerine Cool Mint Antiseptic
Active ingredientMETHYL SALICYLATE, THYMOL, EUCALYPTOL, MENTHOL
Label structure11 sections

Indications and uses

helps prevent and reduce: • plaque • gingivitis

Dosage and administration

• rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night • do not swallow

Storage and handling

this rinse is not intended to replace brushing or flossing store at room temperature cold weather may cloud this product. Its antiseptic properties are not affected.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Purpose

OTC - PURPOSE SECTION

Antiplaque/antigingivitis

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce: • plaque • gingivitis

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use in children under 12 years of age

Ask a dentist

OTC - ASK DOCTOR SECTION

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use

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

• rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night

• do not swallow

Other information

STORAGE AND HANDLING SECTION

  • this rinse is not intended to replace brushing or flossing
  • store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol (21.6%), Sorbitol, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Flavor, 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 - 1 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

LISTERINE ®

COOL MINT ®

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.0 L (1 Qt 1.8 Fl Oz)

Listerine_1Listerine_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN7
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN7
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD7
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD7
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY7
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0791-1Listerine Cool Mint Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007
69968-0791-2Listerine Cool Mint Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15007
69968-0791-3Listerine Cool Mint Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH2507
69968-0791-4Listerine Cool Mint Antiseptic3700 mL in 1 BOTTLE, PLASTICMOUTHWASH37007
69968-0791-5Listerine Cool Mint Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH5007
69968-0791-6Listerine Cool Mint Antiseptic2 in 1 PACKAGEMOUTHWASH27
69968-0791-6Listerine Cool Mint Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15007
69968-0791-9Listerine Cool Mint Antiseptic95 mL in 1 BOTTLE, PLASTICMOUTHWASH957

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0791LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC]7Current NDC, 8 package rows20250308_edb9e374-4dba-5823-e053-2a95a90a3da5.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-079169968-0791-1, 69968-0791-9, 69968-0791-3, 69968-0791-2, 69968-0791-4, 69968-0791-5, 69968-0791-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 Cool Mint AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCedb9e374-4dba-5823-e053-2a95a90a3da52025-03-03WarningsExact identifier
ndc (package): 69968-0791-6
ndc (package): 69968-0791-4
ndc (package): 69968-0791-3
ndc (package): 69968-0791-2
ndc (package): 69968-0791-1
ndc (package): 69968-0791-9
ndc (package): 69968-0791-5
ndc (product): 69968-0791
ndc11 (package): 69968079104
ndc11 (package): 69968079109
ndc11 (package): 69968079102
ndc11 (package): 69968079106
ndc11 (package): 69968079105
ndc11 (package): 69968079101
ndc11 (package): 69968079103
spl id: 2f7de032-dffb-089c-e063-6394a90a673a
spl set id: edb9e374-4dba-5823-e053-2a95a90a3da5

Reported adverse events (FAERS/openFDA)#

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