Mouth Rinse

Manufacturer
United Natural Foods, Inc. dba UNFI | Nice-Pak Products, LLC
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
full-release
Hydrated at
2026-06-01 01:46:16

Label at a glance#

ProductMouth Rinse
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure11 sections

Dosage and administration

adults and children 12 years and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day 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

Storage and handling

 cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰-77⁰F)

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 is 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 and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day 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

STORAGE AND HANDLING SECTION

 cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰-77⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

TEP

OTHER SAFETY INFORMATION

Sealed With Printed Neckband For Your Protection

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Original Listerine Antiseptic Mouthwash.

Adverse reactions

ADVERSE REACTIONS SECTION

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-318-86

Compare to Oringinal Listerine ®Antiseptic Mouthwash active ingredients*

EQUALINE ®

antiseptic

mouthrinse

antigingivitis/antiplaque

  • kills germs that cause bad breath, plaque and gingivitis gum disease

amber

1 L (33.8 FL OZ)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN20
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD20
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY20

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041163254268GTIN-13: 0041163254268
EAN-13: 0041163254268
GTIN-12: 041163254268
UPC-A: 041163254268
GTIN storage (14 digits): 00041163254268
mm02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-318-12Mouth Rinse1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150020
41163-318-13Mouth Rinse1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125020
41163-318-77Mouth Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50020
41163-318-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TK1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
THYMOLACTIVE INGREDIENT3J50XA376E1
EUCALYPTOLACTIVE MOIETYRV6J6604TK1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
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
41163-31841163-318-12, 41163-318-86, 41163-318-77, 41163-318-13

Ingredients#

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

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

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 5 · 265 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
95 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
60 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
95 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
35 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
95 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
60 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route
95 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
30 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii+route
45 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii+route
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii+route
95 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route
45 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route
35 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCONCENTRATE / ORAL12.5 mg/5mlExact identifier — unii+route
45 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
95 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
35 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii+route
95 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
60 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
95 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route
45 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii+route
35 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii+route
45 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
95 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2TABLET / ORAL495 mgExact identifier — unii+route
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+route
95 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
60 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
60 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
60 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
30 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
95 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
95 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
60 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
95 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii+route
45 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / ORAL100 mgExact identifier — unii+route
45 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii+route
35 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / ORAL100 mgExact identifier — unii+route
45 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route
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
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFId9c48c72-b9df-4b3a-bc56-d887196521e22026-02-17Warnings, Adverse reactionsExact identifier
ndc (package): 41163-318-77
ndc (package): 41163-318-13
ndc (package): 41163-318-12
ndc (package): 41163-318-86
ndc (product): 41163-318
ndc11 (package): 41163031813
ndc11 (package): 41163031812
ndc11 (package): 41163031886
ndc11 (package): 41163031877
spl id: 4b074cd2-74ec-e8e8-e063-6394a90ae721
spl set id: d9c48c72-b9df-4b3a-bc56-d887196521e2

Reported adverse events (FAERS/openFDA)#

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