FDA.reportPublic FDA data

Listerine Ultraclean Antiseptic

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:40

Label at a glance#

ProductListerine Ultraclean Antiseptic Cool Mint
Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL
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

store at controlled room temperature 20° - 25° C (68° – 77° F) 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 - 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

  • store at controlled room temperature 20° - 25° C (68° – 77° F)
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6%), sorbitol solution, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green no. 3

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-888-222-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LISTERINE ®
ULTRACLEAN™
WITH EVERFRESH™ TECHNOLOGY

ANTISEPTIC

Controls Tartar Build-up
Kills Plaque & Gingivitis
Germs, Keeps Breath
Fresh for Hours

*vs. brushing alone

COOL MINT ®

500 mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EucalyptolACTIVE INGREDIENTRV6J6604TK1
MentholACTIVE INGREDIENTL7T10EIP3A1
Methyl SalicylateACTIVE INGREDIENTLAV5U5022Y1
ThymolACTIVE INGREDIENT3J50XA376E1
EucalyptolACTIVE MOIETYRV6J6604TK1
MentholACTIVE MOIETYL7T10EIP3A1
Methyl SalicylateACTIVE MOIETYLAV5U5022Y1
ThymolACTIVE MOIETY3J50XA376E1
AlcoholINACTIVE INGREDIENT3K9958V90M1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIM1
FD&C Green No. 3INACTIVE INGREDIENT3P3ONR6O1S1
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M21
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TY1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
SorbitolINACTIVE INGREDIENT506T60A25R1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD41
WaterINACTIVE INGREDIENT059QF0KO0R1
Zinc ChlorideINACTIVE INGREDIENT86Q357L16B1

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
42002-44742002-447-95, 42002-447-73, 42002-447-72, 42002-447-71, 42002-447-70

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 GREEN NO. 33P3ONR6O1SIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 252 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
SorbitolSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / ORAL100 mgExact identifier — unii candidate
23 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Zinc ChlorideZINC CHLORIDE86Q357L16BINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
5 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
SorbitolSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
SorbitolSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUPPOSITORY / VAGINAL2 mgExact identifier — unii candidate
23 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii candidate
15 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin Sodium DihydrateSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii candidate
23 equally ranked IID candidates
SorbitolSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Green No. 3FD&C GREEN NO. 33P3ONR6O1SELIXIR / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates

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
f380023b-fe0d-06d4-e053-2995a90a44d72c9b9404-fbcd-4d8a-afe3-3980bf33ac4e2023-01-30WarningsExact identifier
spl id: f380023b-fe0d-06d4-e053-2995a90a44d7
spl set id: 2c9b9404-fbcd-4d8a-afe3-3980bf33ac4e

Reported adverse events (FAERS/openFDA)#

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