FDA.reportPublic FDA data

Antiseptic

Manufacturer
DZA Brands, LLC | Consumer Product Partners, LLC
Effective date
2024-09-19
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 20:54:36

Label at a glance#

ProductAntiseptic
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure13 sections

Dosage and administration

adults and children 12 years of age and older vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow children under 12 years of age consult a dentist or doctor this rinse is not intended to replace brushing or flossing

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings 

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

OTC - STOP USE SECTION

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children under 12 years of age consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

other information

SPL UNCLASSIFIED SECTION

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

inactive ingredients

INACTIVE INGREDIENT SECTION

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

disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine

Adverse reactions 

ADVERSE REACTIONS SECTION

Distributed by: DZA Brands, LLC

2110 Executive Drive

Salisbury, NC 28147

For product questions or concerns contact us at 1-866-322-2439.  Please include UPC number and code from the package

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healthy

accents

original flavor

antiseptic

mouth rinse

kills germs that cause bad breath, plaque & the gum disease gingivitis

compare to the active

ingredients of Listerine

1 L (33.8 FL OZ)

image descriptionimage description

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
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
55316-31855316-318-86, 55316-318-69

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
CARAMELT9D99G2B1RIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML

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 2 · 106 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / PERIODONTAL155 mgExact identifier — unii candidate
15 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION, SOLUTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCONCENTRATE / ORAL12.5 mg/5mlExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2TABLET / ORAL495 mgExact identifier — unii candidate
15 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / TOPICAL28 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / ORAL100 mgExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / INTRATYMPANIC63 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLOTION / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 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
2528db17-df34-68d1-e063-6294a90af781854085b3-3307-4f54-9d36-00b6fbb061c22024-10-23Warnings, Adverse reactionsExact identifier
spl set id: 854085b3-3307-4f54-9d36-00b6fbb061c2

Reported adverse events (FAERS/openFDA)#

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