FDA.reportPublic FDA data

Listerine Clinical Solutions Gum Health Icy Mint

Manufacturer
Kenvue Brands LLC
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:59:45

Label at a glance#

ProductListerine Clinical Solutions Gum Health Icy Mint
Active ingredientEUCALYPTOL, MENTHOL, THYMOL, METHYL SALICYLATE
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

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, Flavor, Zinc Chloride, Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Sucralose, Red 40

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 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

LISTERINE ®

CLINICAL

SOLUTIONS +

ANTISEPTIC

GUM HEALTH

Powered with Zinc to reduce build up and kills 99.9%

of the germs that cause bleeding and inflammation

(*vs brushing alone)

ICY MINT

1.0 L (1 Qt 1.8 Fl Oz)

Listerine_1Listerine_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN4
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN4
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD4
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD4
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY4
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0818-1Listerine Clinical Solutions Gum Health Icy Mint1000 mL in 1 BOTTLEMOUTHWASH10004
69968-0818-5Listerine Clinical Solutions Gum Health Icy Mint500 mL in 1 BOTTLEMOUTHWASH5004
69968-0818-9Listerine Clinical Solutions Gum Health Icy Mint95 mL in 1 BOTTLEMOUTHWASH954

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0818LISTERINE CLINICAL SOLUTIONS GUM HEALTH ICY MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC]4Current NDC, 3 package rows20250427_06e1122b-1100-43c0-e063-6394a90a2e78.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-081869968-0818-9, 69968-0818-5, 69968-0818-1

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
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
ZINC CHLORIDE86Q357L16BIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C RED NO. 40WZB9127XOAIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
THYMOL3J50XA376EACTIB
METHYL SALICYLATELAV5U5022YACTIB

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 Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
ndc (package): 69968-0818-9
ndc (package): 69968-0818-1
ndc (package): 69968-0818-5
ndc (product): 69968-0818
ndc11 (package): 69968081809
ndc11 (package): 69968081801
ndc11 (package): 69968081805
spl id: 3359f5ff-88d2-5525-e063-6394a90a1a50
spl set id: 06e1122b-1100-43c0-e063-6394a90a2e78

Reported adverse events (FAERS/openFDA)#

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