FDA.reportPublic FDA data

Therabreath Deep Clean Fresh Mint

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:20:13

Label at a glance#

ProductTherabreath Deep Clean Fresh Mint
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Indications and uses

Helps prevent gingivitis, an early form of gum disease and bleeding gums Helps control plaque that leads to gingivitis and bleeding gums

Dosage and administration

Adults and Children 12 years and older Vigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Children 6 years to under 12 years Supervise use. Children under 6 years Do not use.

Storage and handling

This rinse is not intended to replace brushing or flossing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent gingivitis, an early form of gum disease and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • Gingivitis, bleeding, or redness persists for more than 2 weeks.
  • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.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 olderVigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
Children 6 years to under 12 yearsSupervise use.
Children under 6 yearsDo not use.

Other information

STORAGE AND HANDLING SECTION

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Flavor, Glycerin, Poloxamer 407, Sucralose, Water

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL
FREE

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath ™

DENTIST FORMULATED

DEEP CLEAN

ORAL RINSE

KILLS 99.9% OF GERMS
THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS*

ANTISEPTIC

No Alcohol • No Dyes • Non Burning

FRESH MINT

16 fl.oz.
473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251772cetylpyridinium chloride 0.1 % Mucous Membrane Topical SolutionPSN3
1251772cetylpyridinium chloride 1 MG/ML Mucous Membrane Topical SolutionSCD3
1251772cetylpyridinium chloride 0.1 % Mucous Membrane Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-261-01Therabreath Deep Clean Fresh Mint1000 mL in 1 BOTTLE, PLASTICRINSE10003
10237-261-03Therabreath Deep Clean Fresh Mint88.7 mL in 1 BOTTLE, PLASTICRINSE88.73
10237-261-16Therabreath Deep Clean Fresh Mint473 mL in 1 BOTTLE, PLASTICRINSE4733
10237-261-26Therabreath Deep Clean Fresh Mint2 in 1 PACKAGERINSE23
10237-261-26Therabreath Deep Clean Fresh Mint473 mL in 1 BOTTLE, PLASTICRINSE4733

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-26110237-261-16, 10237-261-03, 10237-261-01, 10237-261-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraBreathCETYLPYRIDINIUM CHLORIDEChurch & Dwight Co., Inc.4b803b5f-0d8c-a3e0-e063-6294a90a2ecf2026-01-01WarningsExact identifier
ndc (package): 10237-261-16
ndc11 (package): 10237026116
Therabreath Deep Clean Fresh MintCETYLPYRIDINIUM CHLORIDEChurch & Dwight Co., Inc.19bb1bc2-f4e3-4faa-82a5-656fec4397dd2025-12-05WarningsExact identifier
ndc (package): 10237-261-01
ndc (package): 10237-261-16
ndc (package): 10237-261-26
ndc (package): 10237-261-03
ndc (product): 10237-261
ndc11 (package): 10237026126
ndc11 (package): 10237026116
ndc11 (package): 10237026103
ndc11 (package): 10237026101
spl id: 453a6780-e9fb-e694-e063-6294a90a2122
spl set id: 19bb1bc2-f4e3-4faa-82a5-656fec4397dd

Reported adverse events (FAERS/openFDA)#

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