Listerine Ultraclean Antiseptic

Manufacturer: Kenvue Brands LLC
Effective date: 2024-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 00:36:54

Label at a glance#

ProductListerine Ultraclean Antiseptic Cool Mint

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.

Contacts and useful links#

PhoneLabel contact888-222-0182

PhoneLabel contact215-273-8755

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

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% v/v), Sorbitol, Poloxamer 407, Benzoic Acid, Zinc Chloride, Flavor, Sodium Benzoate, Sucralose, Sodium Saccharin, Green 3

Questions?

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®

ULTRACLEAN

FOR UP TO A 3X

LONGER LASTING

CLEAN FEELING*

*VS. brushing alone

1.5 L (1 Qt 1 Pt 2.7 Fl Oz)

COOL MINT®

Listerine

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	10
2043303	LISTERINE ULTRACLEAN 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash	PSN	10
2043303	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Ultraclean]	SBD	10
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	10
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	10
2043303	Listerine Ultraclean (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	10
2043303	Listerine Ultraclean Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
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
69968-0539-1	Listerine Ultraclean AntisepticCool Mint	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000	10
69968-0539-2	Listerine Ultraclean AntisepticCool Mint	250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	250	10
69968-0539-3	Listerine Ultraclean AntisepticCool Mint	1500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1500	10
69968-0539-4	Listerine Ultraclean AntisepticCool Mint	2 in 1 PACKAGE	MOUTHWASH	2	10
69968-0539-5	Listerine Ultraclean AntisepticCool Mint	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0539	LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]	10	Current NDC, Legacy NDC, 5 package rows	20241114_dd3729c2-fd05-4db0-a542-487bb0f9001f.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Listerine Ultraclean Antiseptic Cool Mint
Eucalyptol, Menthol, unspecified form, Methyl Salicylate, and Thymol
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
BENZOIC ACID
ZINC CHLORIDE
SODIUM BENZOATE
SUCRALOSE
SACCHARIN SODIUM
FD&C GREEN NO. 3
EUCALYPTOL
MENTHOL, UNSPECIFIED FORM
METHYL SALICYLATE
SALICYLIC ACID
THYMOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69968-0539	69968-0539-2, 69968-0539-5, 69968-0539-1, 69968-0539-3, 69968-0539-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
ZINC CHLORIDE	86Q357L16B	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
EUCALYPTOL	RV6J6604TK	ACTIB
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
THYMOL	3J50XA376E	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier ndc (package): 69968-0539-5 ndc (package): 69968-0539-3 ndc (package): 69968-0539-4 ndc (package): 69968-0539-1 ndc (package): 69968-0539-2 ndc (product): 69968-0539 ndc11 (package): 69968053903 ndc11 (package): 69968053901 ndc11 (package): 69968053904 ndc11 (package): 69968053902 ndc11 (package): 69968053905 spl id: 22797442-320d-5c9c-e063-6394a90a20c8 spl set id: dd3729c2-fd05-4db0-a542-487bb0f9001f

Reported adverse events (FAERS/openFDA)#

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