SmartMouth Advance Clinical DDS Formula Mint

Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:12

Label at a glance#

ProductSmartMouth Advance Clinical DDS Formula Mint
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

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (one sample packet) 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. 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

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 (one sample packet) 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

SMARTMOUTH™ IS A TRADEMARK
OF AND DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Pouch

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 • 0.68 FL. OZ. [20 mL] • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - Kit Pouch
PRINCIPAL DISPLAY PANEL - Kit Pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN6
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD6
1251617cetylpyridinium chloride 0.05 % MouthwashSY6

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76357-230-012024-01-30C16284748780-11030e365-292b-111a-e063-dadaa90a10e2SmartMouth™ Advance Clinical DDS™ Formula Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-230-01SmartMouth Advance Clinical DDS Formula Mint1 in 1 POUCHKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-230SMARTMOUTH ADVANCE CLINICAL DDS FORMULA MINT (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]6Legacy NDC, 1 package rows20241215_4dad79f6-f922-4c22-8568-2d9105348a84.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
76357-23076357-230-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
8b44a332-760b-40cc-8918-2aaa3c80829d4dad79f6-f922-4c22-8568-2d9105348a842024-12-12WarningsExact identifier
spl id: 8b44a332-760b-40cc-8918-2aaa3c80829d
spl set id: 4dad79f6-f922-4c22-8568-2d9105348a84

Reported adverse events (FAERS/openFDA)#

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