LISTERINE

Manufacturer: Kenvue Brands LLC
Effective date: 2025-02-28
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-06-01 00:56:44

Label at a glance#

ProductLISTERINE Original Antiseptic

Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL

Label structure10 sections

Dosage and administration

rinse full strength for 30 seconds with 20mL (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.

Contacts and useful links#

PhoneLabel contact888-222-0182

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient	Purpose
Eucalyptol (0.092%)	Antiplaque/antigingivitis
Menthol (0.042%)	Antiplaque/antigingivitis
Methyl Salicylate (0.060%)	Antiplaque/antigingivitis
Thymol (0.064%)	Antiplaque/antigingivitis

Use

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

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 20mL (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 - 1.0 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE®

ORIGINAL

ANTISEPTIC

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

1.0 L (1 Qt 1.8 Fl Oz)

Listerine_1

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1043623	LISTERINE ANTISEPTIC (Mouthwash)	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	PSN	11
1043623	LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash	PSN	11
1043623	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]	SBD	11
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	11
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	11
1043623	Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69968-0400-1	LISTERINEOriginal Antiseptic	1500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1500	11
69968-0400-2	LISTERINEOriginal Antiseptic	250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	250	11
69968-0400-3	LISTERINEOriginal Antiseptic	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000	11
69968-0400-5	LISTERINEOriginal Antiseptic	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500	11
69968-0400-8	LISTERINEOriginal Antiseptic	2 in 1 PACKAGE	MOUTHWASH	2	11
69968-0400-9	LISTERINEOriginal Antiseptic	95 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	95	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0400	LISTERINE ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC, 6 package rows	20250308_78e2e172-09a4-4bf1-9871-d099c49087be.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

LISTERINE Original Antiseptic
Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, and Thymol
WATER
ALCOHOL
BENZOIC ACID
POLOXAMER 407
SODIUM BENZOATE
CARAMEL
EUCALYPTOL
MENTHOL, UNSPECIFIED FORM
METHYL SALICYLATE
SALICYLIC ACID
THYMOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69968-0400	69968-0400-2, 69968-0400-5, 69968-0400-3, 69968-0400-1, 69968-0400-9, 69968-0400-8

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CARAMEL	T9D99G2B1R	IACT
EUCALYPTOL	RV6J6604TK	ACTIB
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
THYMOL	3J50XA376E	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISTERINE Original Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	78e2e172-09a4-4bf1-9871-d099c49087be	2025-02-28	Warnings	Exact identifier ndc (package): 69968-0400-2 ndc (package): 69968-0400-3 ndc (package): 69968-0400-1 ndc (package): 69968-0400-8 ndc (package): 69968-0400-5 ndc (package): 69968-0400-9 ndc (product): 69968-0400 ndc11 (package): 69968040003 ndc11 (package): 69968040008 ndc11 (package): 69968040002 ndc11 (package): 69968040009 ndc11 (package): 69968040001 ndc11 (package): 69968040005 spl id: 2f2db917-d08b-0560-e063-6394a90aba42 spl set id: 78e2e172-09a4-4bf1-9871-d099c49087be

Reported adverse events (FAERS/openFDA)#

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

LISTERINE

Label at a glance#

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Use

Warnings

OTC - DO NOT USE SECTION

OTC - ASK DOCTOR SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

NDC Codes#

Ingredients#

Source Document#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#