FDA.reportPublic FDA data

TheraBreath

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-09-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-09-26 01:01:13

Label at a glance#

ProductTheraBreath Healthy Gums
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Indications and uses

Helps prevent • gingivitis, an early form of gum disease • bleeding gums Helps control plaque that leads to • gingivitis • 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 0.05%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

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

Water, Glycerin, Poloxamer 407, Flavor, Sucralose

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE

SAVE!
VALUE
SIZE

TheraBreath ™

DENTIST FORMULATED

HEALTHY GUMS

ORAL RINSE

HELPS FIGHT GINGIVITIS FOR 24 HOURS*

HELPS REDUCE PLAQUE THAT LEADS TO GUM DISEASE

Reduces Occurrence of Bleeding Gums • Freshens Breath
No Alcohol • No Dyes • Non Burning

CLEAN MINT

33.8 fl. oz.
1 liter

72033408 TheraBreath Healthy Gums 16oz72033408 TheraBreath Healthy Gums 16oz

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
10237-25810237-258-16, 10237-258-03, 10237-258-01, 10237-258-26, 10237-258-21, 10237-258-10, 10237-258-15

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
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-03full-release2026-06-01 01:20:07

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): 10237-258-16
ndc11 (package): 10237025816
3d3505a3-77e1-1402-e063-6294a90ad2a3e06bfc9e-38e5-475b-89c1-026ccfe560312025-12-03WarningsExact identifier
spl set id: e06bfc9e-38e5-475b-89c1-026ccfe56031

Reported adverse events (FAERS/openFDA)#

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