FDA.reportPublic FDA data

Listerine Nightly Reset Anticavity Fluoride Twilight Mint

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:41:22

Label at a glance#

ProductListerine Nightly Reset Anticavity Fluoride Twilight Mint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and children 12 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing supervise children as necessary until capable of using without supervision Children under 12 years of age: consult a dentist or doctor

Storage and handling

store at room temperature cold weather may temporarily cloud this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

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. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older:
    • use twice a day after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • supervise children as necessary until capable of using without supervision
  • Children under 12 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, propylene glycol, xylitol, poloxamer 407, sodium lauryl sulfate, sodium benzoate, phosphoric acid, eucalyptol, flavor, methyl salicylate, thymol, sodium saccharin, menthol, sucralose, disodium phosphate, red 40, blue 1

Questions?

OTC - QUESTIONS SECTION

call toll-free 888-222-0182 or 215-273-8755 (collect). www.listerine.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICAVITY FLUORIDE MOUTHWASH

Sodium Fluoride & Acidulated Phosphate Topical Solution

LISTERINE ®

NEW!

NIGHTLY
RESET™

WORKS HARD
TO HELP ERASE
THE EFFECTS
OF THE DAY

USE BEFORE AND AFTER SLEEP TO:
CLEAN DEEPLY
REPLENISH ENAMEL
DEFEND AGAINST CAVITIES

TWILIGHT MINT™
LESS INTENSE

IMPORTANT:
READ DIRECTIONS
FOR PROPER USE.

800 mL(1.7 pt)

PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-047869968-0478-8, 69968-0478-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
XYLITOLVCQ006KQ1EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
PHOSPHORIC ACIDE4GA8884NNIACT
EUCALYPTOLRV6J6604TKIACT
THYMOL3J50XA376EIACT
METHYL SALICYLATELAV5U5022YIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f6c2a1a0-6f42-298f-e053-6294a90adaa2786e9ba5-d0b0-4e22-a844-b90acbb69c182023-03-13WarningsExact identifier
spl set id: 786e9ba5-d0b0-4e22-a844-b90acbb69c18

Reported adverse events (FAERS/openFDA)#

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