FDA.reportPublic FDA data

SmartMouth Premium Action

Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:48:25

Label at a glance#

ProductSmartMouth Premium Action SmartMouth Advanced Clinical Formula (ACF)
Active ingredientSodium Monofluorophosphate
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate (0.81%) (0.10% w/v of fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Glycerin, Water, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Xanthan Gum, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Zinc Chloride, D&C Yellow #10 and FD&C Blue #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 63114

PRINCIPAL DISPLAY PANEL - 96.4 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smart
mouth™

Anti-Cavity
Toothpaste
with Fluoride

Zn+2

SMART-ZINC™
TECHNOLOGY

Protect • Clean • Repair

Remineralizes Weakened Enamel

Removes Dental Plaque

Dentist Recommended

MILD MINT • NET WT. 3.4 OZ (96.4g)

Principal Display Panel - 96.4 g Tube Label
Principal Display Panel - 96.4 g Tube Label

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
76357-175-002024-01-30C16284748780-1f386c649-9f99-0266-e053-dadaa90a7c1aSmartMouth™ Premium Action Toothpaste SmartMouth™ Toothpaste Advanced Clinical Formula (ACF)
76357-175-002023-02-07C16284748780-1f386c649-9f99-0266-e053-dadaa90a7c1aSmartMouth™ Premium Action Toothpaste SmartMouth™ Toothpaste Advanced Clinical Formula (ACF)
76357-175-002023-01-30C16284748780-1f386c649-9f99-0266-e053-dadaa90a7c1aSmartMouth™ Premium Action Toothpaste SmartMouth™ Toothpaste Advanced Clinical Formula (ACF)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-175-00SmartMouth Premium ActionSmartMouth Advanced Clinical Formula (ACF)96.4 g in 1 TUBEPASTE, DENTIFRICE96.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-175SMARTMOUTH PREMIUM ACTION SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF) (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.]6Legacy NDC, 1 package rows20241225_4926e9a5-7f7a-40aa-b782-e731bfa45190.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76357-17576357-175-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium MonofluorophosphateC810JCZ56QACTIM
Sorbitol506T60A25RIACT
Hydrated SilicaY6O7T4G8P9IACT
GlycerinPDC6A3C0OXIACT
Water059QF0KO0RIACT
Sodium Lauryl Sulfate368GB5141JIACT
Titanium Dioxide15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
Sodium BenzoateOJ245FE5EUIACT
Benzoic Acid8SKN0B0MIMIACT
Saccharin SodiumSB8ZUX40TYIACT
Zinc Chloride86Q357L16BIACT

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
8c89d4e5-d4a2-491a-a98d-6e688c1c87884926e9a5-7f7a-40aa-b782-e731bfa451902024-12-20WarningsExact identifier
spl id: 8c89d4e5-d4a2-491a-a98d-6e688c1c8788
spl set id: 4926e9a5-7f7a-40aa-b782-e731bfa45190

Reported adverse events (FAERS/openFDA)#

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