FDA.reportPublic FDA data

Listerine Antiseptic

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-09-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:15:28

Label at a glance#

ProductListerine 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

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% }
Menthol 0.042% }
Methyl salicylate 0.060% }
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 - 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 room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (26.9%), benzoic acid, poloxamer 407, sodium benzoate, caramel

Questions?

OTC - QUESTIONS SECTION

call 1-888-222-0182, weekdays

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®
ORIGINAL
ANTISEPTIC

Kills Germs that Cause
Bad Breath, Plaque & the
Gum Disease Gingivitis

ADA
Accepted
American
Dental
Association®

500 mL (1.05 Pt)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42002-401-632020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-702020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-712020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-722020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-732020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-942020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-952020-09-14C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-632020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-702020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-712020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-722020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-732020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-942020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic
42002-401-952020-07-22C16284748780-1ab0e2407-3262-f274-e053-dbdaa90a6471Listerine Antiseptic

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
CaramelINACTIVE INGREDIENTT9D99G2B1R1
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M21
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42002-40142002-401-73, 42002-401-72, 42002-401-71, 42002-401-70, 42002-401-63, 42002-401-94, 42002-401-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
EucalyptolRV6J6604TKACTIB
Menthol, Unspecified FormL7T10EIP3AACTIB
Methyl SalicylateLAV5U5022YACTIB
Thymol3J50XA376EACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT
Benzoic Acid8SKN0B0MIMIACT
Poloxamer 407TUF2IVW3M2IACT
Sodium BenzoateOJ245FE5EUIACT
CaramelT9D99G2B1RIACT

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 3 · 141 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CaramelCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii candidate
9 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RLOTION / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2GEL / TOPICAL28 mgExact identifier — unii candidate
15 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMCREAM / VAGINAL10 mgExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RCREAM / TOPICAL0.26 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii candidate
23 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CREAM / TOPICAL13 mgExact identifier — unii candidate
15 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMINJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 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
5514d206-f86c-48c0-998f-0251118c10e156f1e582-807c-43bb-b680-98e13852199f2020-09-09WarningsExact identifier
spl id: 5514d206-f86c-48c0-998f-0251118c10e1
spl set id: 56f1e582-807c-43bb-b680-98e13852199f

Reported adverse events (FAERS/openFDA)#

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