Smile Direct Club

Manufacturer
Nutrix International, LLC
Effective date
2020-01-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:02:56

Label at a glance#

ProductSmile Direct Club
Active ingredientSODIUM FLUORIDE
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. - 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

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

Warnings

WARNINGS SECTION

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

Keep out of reach

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years 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, Stevia Rebaudiana Extract, Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Menthol.

Questions

OTC - QUESTIONS SECTION

800-957-3409

Primary Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Packaging TubePrimary Packaging Tube

Packaging Label - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging CartonPackaging Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73333-126-032022-01-28C16284748780-1d6a99b39-517d-a426-e053-dadaa90af4c29c49660a-7555-e4e7-e053-2995a90a8548

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73333-126-03Smile Direct Club1 in 1 CARTONPASTE, DENTIFRICE13
73333-126-03Smile Direct Club125 g in 1 TUBEPASTE, DENTIFRICE1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73333-126SMILE DIRECT CLUB (SENSITIVITY TOOTHPASTE) PASTE, DENTIFRICE [NUTRIX INTERNATIONAL, LLC]3Legacy NDC, 2 package rows20200117_9c49660a-7555-e4e7-e053-2995a90a8548.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
73333-12673333-126-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
9c49660a-7557-e4e7-e053-2995a90a85489c49660a-7555-e4e7-e053-2995a90a85482020-01-16WarningsExact identifier
spl id: 9c49660a-7557-e4e7-e053-2995a90a8548
spl set id: 9c49660a-7555-e4e7-e053-2995a90a8548

Reported adverse events (FAERS/openFDA)#

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