FDA.reportPublic FDA data

Listerine Cool Mint Antiseptic

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:36:52

Label at a glance#

ProductListerine Cool Mint Antiseptic
Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL
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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Thymol 0.064%

Purposes

OTC - PURPOSE SECTION

Antiplaque/antigingivitis

Uses

INDICATIONS & USAGE SECTION

Helps prevent and reduce:

  • Plaque
  • Gingivitis

Warnings

WARNINGS SECTION

ListerineListerine

OTC - DO NOT USE SECTION

Do not use in children under 12 years of age

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 or Comments?

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 - 1.5 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIC

LISTERINE ®

COOL MINT®

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5L (1 Qt 1 Pt 2.7 fl oz)

Listerine_001Listerine_001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN11
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN11
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD11
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD11
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY11
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY11

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
69968-0550-1Listerine Cool Mint Antiseptic946.353 mL in 1 BOTTLELIQUID946.35311
69968-0550-2Listerine Cool Mint Antiseptic250 mL in 1 BOTTLELIQUID25011
69968-0550-3Listerine Cool Mint Antiseptic3700 mL in 1 BOTTLELIQUID370011
69968-0550-4Listerine Cool Mint Antiseptic1419.529 mL in 1 BOTTLELIQUID1419.52911
69968-0550-5Listerine Cool Mint Antiseptic500 mL in 1 BOTTLELIQUID50011
69968-0550-8Listerine Cool Mint Antiseptic2 in 1 PACKAGELIQUID211
69968-0550-9Listerine Cool Mint Antiseptic95 mL in 1 BOTTLELIQUID9511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0550LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) LIQUID [KENVUE BRANDS LLC]11Current NDC, Legacy NDC, 7 package rows20241114_9e97e4f8-80c2-44e0-862c-0dfca392a436.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
69968-055069968-0550-9, 69968-0550-2, 69968-0550-5, 69968-0550-1, 69968-0550-4, 69968-0550-3, 69968-0550-8

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML · Source PDF

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, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
ndc (package): 69968-0550-2
ndc (package): 69968-0550-3
ndc (package): 69968-0550-8
ndc (package): 69968-0550-1
ndc (package): 69968-0550-4
ndc (package): 69968-0550-9
ndc (package): 69968-0550-5
ndc (product): 69968-0550
ndc11 (package): 69968055001
ndc11 (package): 69968055004
ndc11 (package): 69968055009
ndc11 (package): 69968055002
ndc11 (package): 69968055005
ndc11 (package): 69968055008
ndc11 (package): 69968055003
spl id: 22799002-2553-5bc1-e063-6394a90a8fa0
spl set id: 9e97e4f8-80c2-44e0-862c-0dfca392a436

Reported adverse events (FAERS/openFDA)#

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