FDA.reportPublic FDA data

Listerine FreshBurst Antiseptic

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:36:49

Label at a glance#

ProductListerine FreshBurst Antiseptic
Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL
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

Ask a dentist if symptoms persist

OTC - ASK DOCTOR SECTION


Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use

Keep out of reach of children.

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, Sodium Saccharin, Flavor, Sodium Benzoate, Yellow 10, 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 - 1500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIC

LISTERINE ®

FRESHBURST ®

FOR A FRESHER &

CLEANER MOUTH THAN

BRUSHING ALONE

ADA

Accepted

American

Dental

Association ®

1.5 L (1 Qt 1 Pt 2.7 fl oz)

Listerine_001Listerine_001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN9
1043623LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % MouthwashPSN9
1043623eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]SBD9
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD9
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY9
1043623Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) MouthwashSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0239-1Listerine FreshBurst Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10009
69968-0239-2Listerine FreshBurst Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH2509
69968-0239-3Listerine FreshBurst Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15009
69968-0239-5Listerine FreshBurst Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH5009
69968-0239-8Listerine FreshBurst Antiseptic2 in 1 PACKAGEMOUTHWASH29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0239LISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 5 package rows20241114_62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-023969968-0239-5, 69968-0239-2, 69968-0239-1, 69968-0239-3, 69968-0239-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

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 FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
ndc (package): 69968-0239-1
ndc (package): 69968-0239-3
ndc (package): 69968-0239-8
ndc (package): 69968-0239-5
ndc (package): 69968-0239-2
ndc (product): 69968-0239
ndc11 (package): 69968023905
ndc11 (package): 69968023908
ndc11 (package): 69968023903
ndc11 (package): 69968023902
ndc11 (package): 69968023901
spl id: 22634de5-9318-1b56-e063-6394a90a6245
spl set id: 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8

Reported adverse events (FAERS/openFDA)#

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