FDA.reportPublic FDA data

Smile Direct Club

Manufacturer
Nutrix, LLC | Nutrix,LLC
Effective date
2019-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:38

Label at a glance#

ProductSmile Direct Club
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of dental cavities.

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. - 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%

Purpose

OTC - PURPOSE SECTION

Anticavity.

Indications and Usage Section

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immedieately.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 year of age.

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.

- 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, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Menthol, Stevia Rebaudiana Extract, Carrageenan.

Questions?

REFERENCES SECTION

800-957-3409

Principle package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Packaging LabelPrimary Packaging Label

Primary Packaging - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Packaging - CartonPrimary Packaging - Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73333-125-012021-01-29C16284748780-1ba0f9c33-3e7f-a910-e053-dadaa90a0b85936893e2-518e-5139-e053-2a95a90a076c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73333-125-01Smile Direct Club1 in 1 CARTONPASTE, DENTIFRICE11
73333-125-01Smile Direct Club125 g in 1 TUBEPASTE, DENTIFRICE1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73333-125SMILE DIRECT CLUB (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [NUTRIX, LLC]1Legacy NDC, 2 package rows20191123_936893e2-518e-5139-e053-2a95a90a076c.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73333-12573333-125-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
MINTFV98Z8GITPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
CARRAGEENAN5C69YCD2YJIACT
SORBITOL506T60A25RIACT
MENTHOLL7T10EIP3AIACT

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
936893e2-518f-5139-e053-2a95a90a076c936893e2-518e-5139-e053-2a95a90a076c2019-09-25WarningsExact identifier
spl id: 936893e2-518f-5139-e053-2a95a90a076c
spl set id: 936893e2-518e-5139-e053-2a95a90a076c

Reported adverse events (FAERS/openFDA)#

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