Mouth Rinse

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:44:26

Label at a glance#

ProductMouth Rinse
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

Adults and children under 12 years of age and older: •use twice daily 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 anything for 30 minutes after rinsing •instruct children under 12 years of age in good rinsing habits (to minimize swallowing) •supervise children as necess...

Storage and handling

•store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F) •cold weather may temporarily cloud this product

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

for this product

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 under 12 years of age and older:

•use twice daily 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 anything for 30 minutes after rinsing

•instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

•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 controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ®Total Care Fresh Mint Anticavity Mouthwash.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

TOPCO VIJA0219 QUESTIONS? 1-888-423-0139 topcare@topco.com

TOPCO VIJA1024 QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

DSP-TN-21091

DSP-MO-20087

Scan her for more information or call 1-888-423-0139

QUALITY GUARANTEED

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO LISTERINE ®TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH*

TopCare ®

everyday

FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

EUCALYPTUS MINT

6 Benefits

  • Helps prevent cavities
  • Strengthens teeth
  • Restores enamel
  • Kills bad breath germs
  • Freshens breath
  • Cleans entire mouth**

**This product is not intended to replace brushing or flossing

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038904sodium fluoride 0.0221 % (fluoride ion 0.01 % ) MouthwashPSN16
1038904sodium fluoride 0.221 MG/ML MouthwashSCD16
1038904sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral RinseSY16

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-001-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M21
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA741
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

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
36800-00136800-001-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 298 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
36 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route
46 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii+route
52 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii+route
46 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii+route
52 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route
46 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
46 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii+route
46 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SYRUP / ORAL70 mgExact identifier — unii+route
10 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
46 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCONCENTRATE / ORAL0.02 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii+route
46 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii+route
52 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
46 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
46 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
36 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii+route
46 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii+route
46 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route
52 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route
46 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
52 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii+route
46 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
46 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
46 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route
46 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii+route
52 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, DELAYED RELEASE / ORAL199 mgExact identifier — unii+route
46 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii+route
52 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii+route
52 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LELIXIR / ORAL27.5 mg/5mlExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
46 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
36 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8ELIXIR / ORAL5.4 mg/5mlExact identifier — unii+route
52 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74FILM, SOLUBLE / ORAL9 mgExact identifier — unii+route
10 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET / ORAL0.04 mgExact identifier — unii+route
10 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
52 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii+route
46 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 RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-001-86
ndc (product): 36800-001
ndc11 (package): 36800000186
spl id: 4ab7fbe5-4281-9c7d-e063-6394a90a2392
spl set id: c640adc0-e178-4b6a-af44-07d2f7da81d3

Reported adverse events (FAERS/openFDA)#

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