Listerine Ultraclean Antiseptic

Manufacturer
Kenvue Brands LLC
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:59:03

Label at a glance#

ProductListerine Ultraclean Antiseptic Cool Mint
Active ingredientTHYMOL, EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Eucalyptol (0.092%)Antiplaque/antigingivitis
Menthol (0.042%)Antiplaque/antigingivitis
Methyl Salicylate (0.060%)Antiplaque/antigingivitis
Thymol (0.064%)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/PHARMACIST 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:
KENVUE BRANDS LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIC

LISTERINE ®

ULTRACLEAN ®

ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH

4 IN 1

BENEFITS

1. HELPS REDUCE & PREVENT HARD

TO REMOVE BUILDUP (tartar)

2. LONGER LASTING CLEAN
3. FIGHTS PLAQUE & GINGIVITIS
4. KILLS 99.9% OF GERMS *

vs. brushing alone *bad breath germs

COOL MINT ®

500 mL (1.05 Pt)

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 % MouthwashPSN6
2043303LISTERINE ULTRACLEAN 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN6
2043303eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Ultraclean]SBD6
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD6
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY6
2043303Listerine Ultraclean (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY6
2043303Listerine Ultraclean Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0788-1Listerine Ultraclean AntisepticCool Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10006
69968-0788-2Listerine Ultraclean AntisepticCool Mint1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15006
69968-0788-5Listerine Ultraclean AntisepticCool Mint500 mL in 1 BOTTLE, PLASTICMOUTHWASH5006
69968-0788-9Listerine Ultraclean AntisepticCool Mint1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15006
69968-0788-9Listerine Ultraclean AntisepticCool Mint2 in 1 PACKAGEMOUTHWASH26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0788LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC]6Current NDC, 5 package rows20250413_ee467ec4-bd5e-644a-e053-2a95a90ac273.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
69968-078869968-0788-5, 69968-0788-1, 69968-0788-2, 69968-0788-9

Ingredients#

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

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

Source Document#

Source XML

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee467ec4-bd5e-644a-e053-2a95a90ac2732025-04-10WarningsExact identifier
ndc (package): 69968-0788-9
ndc (package): 69968-0788-5
ndc (package): 69968-0788-1
ndc (package): 69968-0788-2
ndc (product): 69968-0788
ndc11 (package): 69968078801
ndc11 (package): 69968078805
ndc11 (package): 69968078802
ndc11 (package): 69968078809
spl id: 322bfae8-c5a1-449b-e063-6294a90a596e
spl set id: ee467ec4-bd5e-644a-e053-2a95a90ac273