SmartMouth

Manufacturer: Triumph Pharmaceuticals Inc.
Effective date: 2024-12-30
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:50:03

Label at a glance#

ProductSmartMouth Advance Clinical Formula

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 ...

Contacts and useful links#

PhoneLabel contact1-800-492-7040

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 63132
Made in USA ©2011

PRINCIPAL DISPLAY PANEL - 170 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. 6 OZ (170g)

Principal Display Panel - 170 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1048117	sodium monofluorophosphate 0.8 % Toothpaste	PSN	9
1048117	sodium monofluorophosphate 0.008 MG/MG Toothpaste	SCD	9
1048117	sodium monofluorophosphate 0.0081 MG/MG Toothpaste	SY	9
1048117	sodium monofluorophosphate 0.8 % Toothpaste	SY	9

DailyMed Product Concepts#

Product concept, Relation, Version table
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76357-106-04	2024-12-31	C162847	48780-1	f386c64a-3726-0266-e053-dadaa90a7c1a	Smart Mouth™ ADVANCED CLINICAL FORMULA™ TOOTHPASTE
76357-106-04	2023-01-30	C162847	48780-1	f386c64a-3726-0266-e053-dadaa90a7c1a	Smart Mouth™ ADVANCED CLINICAL FORMULA™ TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76357-106-04	SmartMouth Advance Clinical Formula	170 g in 1 TUBE	PASTE, DENTIFRICE	170		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76357-106	SMARTMOUTH ADVANCE CLINICAL FORMULA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.]	9	Legacy NDC, 1 package rows	20250101_9caa17c9-f864-4c9c-b2ea-dfaed0c6708e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1
Zinc Chloride	INACTIVE INGREDIENT	86Q357L16B	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

SmartMouth Advance Clinical Formula
Sodium Monofluorophosphate
Fluoride Ion
Sorbitol
Hydrated Silica
Glycerin
Water
Sodium Lauryl Sulfate
Titanium Dioxide
Xanthan Gum
Sodium Benzoate
Benzoic Acid
Saccharin Sodium
Zinc Chloride
D&C Yellow No. 10
FD&C Blue No. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76357-106	76357-106-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Monofluorophosphate	C810JCZ56Q	ACTIM
Sorbitol	506T60A25R	IACT
Hydrated Silica	Y6O7T4G8P9	IACT
Glycerin	PDC6A3C0OX	IACT
Water	059QF0KO0R	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Xanthan Gum	TTV12P4NEE	IACT
Sodium Benzoate	OJ245FE5EU	IACT
Benzoic Acid	8SKN0B0MIM	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Zinc Chloride	86Q357L16B	IACT
D&C Yellow No. 10	35SW5USQ3G	IACT
FD&C Blue No. 1	H3R47K3TBD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 395 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Zinc Chloride	ZINC CHLORIDE	86Q357L16B	SOLUTION/ DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / ORAL	15 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Zinc Chloride	ZINC CHLORIDE	86Q357L16B	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6f5c77f8-7ff3-45bc-9643-ce657caf234d			9caa17c9-f864-4c9c-b2ea-dfaed0c6708e	2024-12-30	Warnings	Exact identifier spl id: 6f5c77f8-7ff3-45bc-9643-ce657caf234d spl set id: 9caa17c9-f864-4c9c-b2ea-dfaed0c6708e

Reported adverse events (FAERS/openFDA)#

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