FDA.reportPublic FDA data

SmartMouth

Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:42:42

Label at a glance#

ProductSmartMouth Clinical Gum and Plaque Formula
Active ingredientCetylpyridinium Chloride
Label structure15 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

Adults and children 12 years of age and older: vigorously swish 20 milliliters 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.

Storage and handling

This rinse is not intended to replace brushing or flossing.

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

  • Adults and children 12 years of age and older: vigorously swish 20 milliliters 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.

Other information

STORAGE AND HANDLING SECTION

  • This rinse is not intended to replace brushing or flossing.

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, 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 or comments

OTC - QUESTIONS SECTION

1-800-492-7040

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63114

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Oral Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Clinical
Zinc Activated Oral Rinse™

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Prescription Strength Formula+

Gingivitis & Bleeding Gums Protection

Dentist Recommended

Zinc Promotes Oral Health & Boosts Immunity

CLEAN MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Breath Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW &
IMPROVED
POUR

MIXES TO
ACTIVATE
2 Powerful Solutions

BLOCKS
ODORS

FRESHENS
BREATH

smart
mouth™

Clinical
Scientifically Proven
Smart-Zinc™ Technology

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Prescription Strength+

ANTI-PLAQUE

ANTI-GINGIVITIS

CLEAN MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE

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

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW &
IMPROVED
POUR

MIXES TO
ACTIVATE
2 Powerful Solutions

BLOCKS
ODORS

FRESHENS
BREATH

smart
mouth™

Clinical
Scientifically Proven
Smart-Zinc™ Technology

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Prescription Strength+

ANTI-PLAQUE

ANTI-GINGIVITIS

CLEAN MINT • 32 FL. OZ. (946 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Clinical
Zinc Activated Oral Rinse™

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Prescription Strength Formula+

Gingivitis & Bleeding Gums Protection

Dentist Recommended

Zinc Promotes Oral Health & Boosts Immunity

CLEAN MINT • 10 FL. OZ. (296 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Clinical
Zinc Activated Oral Rinse™

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Prescription Strength Formula+

Gingivitis & Bleeding Gums Protection

Dentist Recommended

Zinc Promotes Oral Health & Boosts Immunity

CLEAN MINT • 10.82 FL. OZ. (320 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN8
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD8
1251617cetylpyridinium chloride 0.05 % MouthwashSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76357-210-012024-01-30C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-211-012024-01-30C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-250-092024-01-30C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-255-012024-01-30C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-250-092021-12-01C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-255-012021-12-01C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-250-092021-01-29C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula
76357-255-012021-01-29C16284748780-1ba0f9c33-2a6a-a910-e053-dadaa90a0b85SmartMouth™ Mouthwash Gum & Plaque Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-210-01SmartMouth Clinical Gum and Plaque Formula1 in 1 CELLO PACKKIT18
76357-290-01SmartMouth Clinical Gum and Plaque Formula296 mL in 1 BOTTLE, PLASTICLIQUID296 mL500 mg in 20mL8
76357-211-01SmartMouth Clinical Gum and Plaque Formula1 in 1 CELLO PACKKIT18
76357-250-09SmartMouth Clinical Gum and Plaque Formula1 in 1 CELLO PACKKIT18
76357-255-01SmartMouth Clinical Gum and Plaque Formula1 in 1 CELLO PACKKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-210SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]8Legacy NDC, 2 package rows20241215_0f836ac2-eb0e-483f-9374-ec8e511e32b6.zip
76357-211SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]8Legacy NDC, 1 package rows20241215_0f836ac2-eb0e-483f-9374-ec8e511e32b6.zip
76357-250SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]8Legacy NDC, 1 package rows20241215_0f836ac2-eb0e-483f-9374-ec8e511e32b6.zip
76357-255SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]8Legacy NDC, 1 package rows20241215_0f836ac2-eb0e-483f-9374-ec8e511e32b6.zip
76357-290SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]8Unmatched20241215_0f836ac2-eb0e-483f-9374-ec8e511e32b6.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76357-25076357-250-09
76357-25576357-255-01
76357-21076357-210-01
76357-29076357-290-01
76357-21176357-211-01
76357-291

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 76 matching rows.

Name, UNII, Kind table
NameUNIIKind
WhiteCOLR
Water059QF0KO0RINGR
Sodium BenzoateOJ245FE5EUINGR
Sodium ChloriteG538EBV4VFINGR
Benzoic Acid8SKN0B0MIMINGR
Cetylpyridinium ChlorideD9OM4SK49PACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Poloxamer 407TUF2IVW3M2IACT
Propylene Glycol6DC9Q167V3IACT
Poloxamer 1241S66E28KXAIACT
Zinc Chloride86Q357L16BIACT
Sodium BenzoateOJ245FE5EUIACT
Benzoic Acid8SKN0B0MIMIACT
Saccharin SodiumSB8ZUX40TYIACT
Sodium Chloride451W47IQ8XIACT
Benzyl AlcoholLKG8494WBHIACT
D&C Yellow No. 1035SW5USQ3GIACT
FD&C Blue No. 1H3R47K3TBDIACT
WhiteCOLR
Water059QF0KO0RINGR
Sodium BenzoateOJ245FE5EUINGR
Sodium ChloriteG538EBV4VFINGR
Benzoic Acid8SKN0B0MIMINGR
Cetylpyridinium ChlorideD9OM4SK49PACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Poloxamer 407TUF2IVW3M2IACT
Propylene Glycol6DC9Q167V3IACT
Poloxamer 1241S66E28KXAIACT
Zinc Chloride86Q357L16BIACT
Sodium BenzoateOJ245FE5EUIACT
Benzoic Acid8SKN0B0MIMIACT
Saccharin SodiumSB8ZUX40TYIACT
Sodium Chloride451W47IQ8XIACT
Benzyl AlcoholLKG8494WBHIACT
D&C Yellow No. 1035SW5USQ3GIACT
FD&C Blue No. 1H3R47K3TBDIACT
WhiteCOLR
Water059QF0KO0RINGR

Source Document#

Source XML · Source PDF

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
c8a2afc5-70ce-40c0-9eff-87c338050feb0f836ac2-eb0e-483f-9374-ec8e511e32b62024-12-11WarningsExact identifier
spl id: c8a2afc5-70ce-40c0-9eff-87c338050feb
spl set id: 0f836ac2-eb0e-483f-9374-ec8e511e32b6

Reported adverse events (FAERS/openFDA)#

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