Indications and uses
Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.
Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.
Use after your normal brushing and flossing routine Adults and children 12 years of age & older: vigorously swish 20 mL of rinse (pour to indicator line on cap) twice a day for 30 seconds and then spit out. Do not swallow. Children 6 years to under 12 years of age: supervise use. Children under 6 years of age: do not use unless directed by a healthcare professional.
Drug Facts
Cetylpyridinium Chloride 0.05% (when mixed as directed)
Anti-gingivitis/Anti-plaque
Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.
Ask a dentist if symptoms persist or condition worsens after regular use.
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.
Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Aloe Vera, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Sodium Chloride, Benzyl Alcohol, D&C Yellow No. 10, FD&C Blue No. 1
1-800-492-7040
DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63141
NEW &
IMPROVED
POUR
MIXES TO
ACTIVATE
2 Powerful Solutions
BLOCKS
ODORS
FRESHENS
BREATH
smart
mouth™
Gum Health
Scientifically Proven
Smart-Zinc™ Technology
24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE
Advanced Germ Killing+
BLEEDING GUMS PROTECTION
SOOTHES WITH NATURAL ALOE
MILD MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE

| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76357-509-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6bd8-111a-e063-dadaa90a10e2 | SmartMouth™ Mouthwash SmartMouth™ Gum Health Zinc Activated Formula |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76357-509-01 | SmartMouth SmartMouth Gum Health Zinc Activated Formula | 1 in 1 BOTTLE | KIT | 1 | 2 | |
| 76357-599-02 | SmartMouth SmartMouth Gum Health Zinc Activated Formula | 237 mL in 1 BOTTLE | LIQUID | 237 mL | 500 mg in 20mL | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76357-509 | SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.] | 2 | 2 package rows | 20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.zip |
| 76357-599 | SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.] | 2 | Unmatched | 20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76357-509 | 76357-509-01 |
| 76357-599 | 76357-599-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Water | 059QF0KO0R | INGR |
| Sodium Benzoate | OJ245FE5EU | INGR |
| Sodium Chlorite | G538EBV4VF | INGR |
| Benzoic Acid | 8SKN0B0MIM | INGR |
| Cetylpyridinium Chloride | D9OM4SK49P | ACTIB |
| Water | 059QF0KO0R | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Poloxamer 407 | TUF2IVW3M2 | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| ALOE | V5VD430YW9 | IACT |
| POLOXAMER 124 | 1S66E28KXA | IACT |
| Zinc Chloride | 86Q357L16B | IACT |
| SODIUM | 9NEZ333N27 | IACT |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| Sodium Chloride | 451W47IQ8X | IACT |
| Benzyl Alcohol | LKG8494WBH | IACT |
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 |
|---|---|---|---|---|---|---|
| 5867dfdf-23b1-4d04-bb64-bb5d957cd168 | c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4 | 2024-12-12 | Warnings | 5867dfdf-23b1-4d04-bb64-bb5d957cd168 c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.