SmartMouth

Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:32

Label at a glance#

ProductSmartMouth SmartMouth Gum Health Zinc Activated Formula
Active ingredientCetylpyridinium Chloride
Label structure10 sections

Indications and uses

Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05% (when mixed as directed)

Purpose

OTC - PURPOSE SECTION

Anti-gingivitis/Anti-plaque

Uses

INDICATIONS & USAGE SECTION

Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a dentist if symptoms persist or condition worsens after regular use.

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

  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-492-7040

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - Kit Label
PRINCIPAL DISPLAY PANEL - Kit Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD2
1251617cetylpyridinium chloride 0.05 % MouthwashSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76357-509-012024-01-30C16284748780-11030e365-6bd8-111a-e063-dadaa90a10e2SmartMouth™ Mouthwash SmartMouth™ Gum Health Zinc Activated Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-509-01SmartMouth SmartMouth Gum Health Zinc Activated Formula1 in 1 BOTTLEKIT12
76357-599-02SmartMouth SmartMouth Gum Health Zinc Activated Formula237 mL in 1 BOTTLELIQUID237 mL500 mg in 20mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-509SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]22 package rows20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.zip
76357-599SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]2Unmatched20241215_c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76357-50976357-509-01
76357-59976357-599-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5867dfdf-23b1-4d04-bb64-bb5d957cd168c03bc577-8345-4b69-bc4e-8f0a2b9fa0a42024-12-12WarningsExact identifier
spl id: 5867dfdf-23b1-4d04-bb64-bb5d957cd168
spl set id: c03bc577-8345-4b69-bc4e-8f0a2b9fa0a4

Reported adverse events (FAERS/openFDA)#

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