FDA.reportPublic FDA data

LISTERINE ® ESSENTIAL CARE ® GEL

Manufacturer
Kenvue Brands LLC
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:39:11

Label at a glance#

ProductListerine Essential Care
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure11 sections

Dosage and administration

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician. children 2-6 years use a pea sized amount instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision. children under 2 years of age: as...

Storage and handling

Store at Room Temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.
    • children 2-6 years use a pea sized amount
    • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision.
  • children under 2 years of age: ask a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, yellow 10

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 - 119 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LISTERINE ®

ESSENTIAL CARE ®

FLUORIDE ANTICAVITY TOOTHPASTE

ORIGINAL GEL

  • FRESHENS BREATH
  • THE LISTERINE ® WAY

POWERFULL MINT GEL

Kills the Germs

that Cause Bad Breath

Helps Prevent Cavities

Removes Stains

NET WT. 4.2 OZ. (119 g)

Listerine_1Listerine_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312547434553GTIN-13: 0312547434553
EAN-13: 0312547434553
GTIN-12: 312547434553
UPC-A: 312547434553
GTIN storage (14 digits): 00312547434553		Listerine_1.jpg
Data codeCode 12830055082Listerine_1.jpg
Data codeData Matrix30060938Listerine_1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0701-4Listerine Essential Care119 g in 1 TUBEGEL, DENTIFRICE1195
69968-0701-4Listerine Essential Care1 in 1 CARTONGEL, DENTIFRICE15

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-070169968-0701-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
EUCALYPTOLRV6J6604TKIACT
METHYL SALICYLATELAV5U5022YIACT
THYMOL3J50XA376EIACT
PHOSPHORIC ACIDE4GA8884NNIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM PHOSPHATESE337SVY37IACT
XANTHAN GUMTTV12P4NEEIACT
BENZOIC ACID8SKN0B0MIMIACT
SPEARMINT OILC3M81465G5IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-11-11full-release2026-06-01 00:36:52

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 Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
ndc (package): 69968-0701-4
ndc (product): 69968-0701
ndc11 (package): 69968070104
spl id: 40c937f3-618c-1c3d-e063-6294a90a35cf
spl set id: 90b5c3d8-baa4-44ab-8f73-e177007f0219

Reported adverse events (FAERS/openFDA)#

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