Indications and uses
helps prevent • gingivitis, an early form of gum disease • bleeding gums helps control plaque that leads to • gingivitus • bleeding gums
TheraBreath
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2026-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:48:48
Label at a glance#
ProductTheraBreath
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure20 sections
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 rinse. children 6 years to under 12 years supervise use children under 6 years do not use
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
TheraBreath Healthy Gums + Deep Clean Variety Pack
Drug Facts
TheraBreath Healthy Gums Oral Rinse
Active ingredient
Cetylpyridinium chloride 0.05%
Purpose
Antigingivitis/Antiplaque
Uses
- helps prevent • gingivitis, an early form of gum disease • bleeding gums
- helps control plaque that leads to • gingivitus • bleeding gums
WARNINGS SECTION
Warnings
Stop use and ask a dentist if
- 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.
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
| 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 rinse. |
| children 6 years to under 12 years | supervise use |
| children under 6 years | do not use |
Other information
- this rinse is not intended to replace brushing or flossing
do not use both oral rinses together.
Inactive ingredients
water, glycerin, poloxamer 407, flavor, sucralose
OTC - QUESTIONS SECTION
Church & Dwight Co., Inc.
PHONE: 1-800-973-7374
WEB: THERABREATH.COM
Drug Facts
TheraBreath Deep Clean Oral Rinse
Active Ingredient
Cetylpyridinium chloride 0.1%
Purpose
Antigingivitis/Antiplaque
Uses
helps prevent • gingivitis, an early form of gum disease • bleeding gums
helps control plaque that leads to • gingivitus • bleeding gums
WARNINGS SECTION
Warnings
Stop use and ask a dentist if
- 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.
Keep out of reachof 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
| 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 |
Other information
- this rinse is not intended to replace brushing or flossing
do not use both oral rinses together.
Inactive ingredients
water, glycerin, poloxamer 407, flavor, sucralose
OTC - QUESTIONS SECTION
Church & Dwight Co., Inc.
PHONE: 1-800-973-7374
WEB: THERABREATH.COM
Principal Display Panel
TheraBreath TM
HEALTHY GUMS + DEEP CLEAN
ANTIGINGIVITIS/ANTIPLAQUE VARIETY PACK
Add TheraBreath to your swishy time routine for healthy gums or a deep clean
Helps fight gingivitis for 12 hours
Kills 99.9% of germs that cause bad breath, plaque & gingivitis*
*in laboratory tests
TheraBreath HEALTHY GUMS CLEAN MINT
TheraBreath DEEP CLEAN FRESH MINT
2 BOTTLES 16 FL OZ (1 PT) 473 mL each; 32 FL OZ (1 qt) 946 mL TOTAL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-258-16 | TheraBreath | 473 mL in 1 BOTTLE, PLASTIC | RINSE | 473 mL | 0.01 mg in 20mL | 1 |
| 10237-261-16 | TheraBreath | 473 mL in 1 BOTTLE, PLASTIC | RINSE | 473 mL | 20 mg in 20mL | 1 |
| 10237-269-01 | TheraBreath | 1 in 1 CARTON | KIT | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- TheraBreath
- Cetylpyridinium chloride
- Therabreath Deep Clean Fresh Mint
- WATER
- GLYCERIN
- CETYLPYRIDINIUM
- SUCRALOSE
- POLOXAMER 407
- TheraBreath Healthy Gums
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-269 | 10237-269-01 |
| 10237-261 | 10237-261-16 |
| 10237-258 | 10237-258-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CETYLPYRIDINIUM CHLORIDE | D9OM4SK49P | ACTIB |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| CETYLPYRIDINIUM CHLORIDE | D9OM4SK49P | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TheraBreath | CETYLPYRIDINIUM CHLORIDE | Church & Dwight Co., Inc. | 4b803b5f-0d8c-a3e0-e063-6294a90a2ecf | 2026-01-01 | Warnings | 10237-261-16 10237-258-16 10237-269-01 10237-269 10237026116 10237025816 10237026901 4b803b5f-0d8d-a3e0-e063-6294a90a2ecf 4b803b5f-0d8c-a3e0-e063-6294a90a2ecf |
| Therabreath Deep Clean Fresh Mint | CETYLPYRIDINIUM CHLORIDE | Church & Dwight Co., Inc. | 19bb1bc2-f4e3-4faa-82a5-656fec4397dd | 2025-12-05 | Warnings | 10237-261-16 10237-261 10237026116 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.