FDA.reportPublic FDA data

Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash

Manufacturer
Kenvue Brands LLC
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:26:19

Label at a glance#

ProductListerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash
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

Warnings

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 (26.9% v/v), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel

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®

ORIGINAL

ANTISEPTIC

POWERED BY ESSENTIAL OILS

FRESH &

CLEAN

KILLS 99.9% OF GERMS*

*THAT CAUSE BAD BREATH,

PLAQUE & GINGIVITIS

1.0 L (1 Qt 1.8FL Oz)

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 % MouthwashPSN1
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD1
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312547701525GTIN-13: 0312547701525
EAN-13: 0312547701525
GTIN-12: 312547701525
UPC-A: 312547701525
GTIN storage (14 digits): 00312547701525		Listerine -1.jpg
QR code linkQR Code2d.kenvue.com/01/00312547701525Listerine -1.jpg
Data codeData Matrix30061520Listerine -1.jpg
Data codeData Matrix30061522Listerine -1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0955-1Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash1000 mL in 1 BOTTLEMOUTHWASH10001
69968-0955-2Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash1500 mL in 1 BOTTLEMOUTHWASH15001
69968-0955-8Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash1500 mL in 1 BOTTLEMOUTHWASH15001
69968-0955-8Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash2 in 1 TRAYMOUTHWASH21

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
69968-095569968-0955-1, 69968-0955-8, 69968-0955-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
EUCALYPTOLRV6J6604TKACTIB
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARAMELT9D99G2B1RIACT
MENTHOLL7T10EIP3AACTIB

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 Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
ndc (package): 69968-0955-1
ndc (package): 69968-0955-8
ndc (package): 69968-0955-2
ndc (product): 69968-0955
ndc11 (package): 69968095501
ndc11 (package): 69968095502
ndc11 (package): 69968095508
spl id: 456d45fb-f520-d382-e063-6294a90ab2be
spl set id: 456d45e8-bf6d-31c4-e063-6394a90a5c00

Reported adverse events (FAERS/openFDA)#

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