FDA.reportPublic FDA data

Listerine Cool Mint Antiseptic

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:39

Label at a glance#

ProductListerine Cool Mint Antiseptic
Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL
Label structure10 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

Listerine 95 mLListerine 95 mL

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)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ListerineListerine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN2
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN2
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD2
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD2
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY2
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY2

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
67751-216-01Listerine Cool Mint Antiseptic1 in 1 BLISTER PACKLIQUID12
67751-216-01Listerine Cool Mint Antiseptic95 mL in 1 BOTTLELIQUID952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-216LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) LIQUID [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 2 package rows20241004_f5f26e2f-8a1f-4687-e053-2a95a90ae378.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
67751-21667751-216-01
69968-0550

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

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 · 2 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 (product): 69968-0550
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
ndc (package): 67751-216-01
ndc (product): 67751-216
ndc11 (package): 67751021601
spl id: 23956e55-6b5a-095b-e063-6394a90a6f1d
spl set id: f5f26e2f-8a1f-4687-e053-2a95a90ae378

Reported adverse events (FAERS/openFDA)#

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