FDA.reportPublic FDA data

Supersmile

Manufacturer
Robell Research, Inc.
Effective date
2019-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:53

Label at a glance#

ProductSupersmile
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Indications and uses

Aids in the prevention of cavities.

Dosage and administration

For best results: Brush teeth thoroughly after each meal, at least twice a day or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or doctor before use.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate (0.14% w/v as fluoride ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity.

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities.

Warnings:

WARNINGS SECTION

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

For best results: Brush teeth thoroughly after each meal, at least twice a day or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or doctor before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Calprox®, Citric Acid, Dicalcium Phosphate, Sodium Bicarbonate, Titanium Dioxide, Calcium Carbonate, Cellulose Gum, Flavor, Sodium Perborate, Magnesium Carbonate, Corn Starch, Sodium Lauryl Suloacelate, Sodium Saccharin.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

supersmile®

extra white

lotus peach mintea

professional

extra

whitening

toothpaste

Contains Fluoride

7 oz / 198.5 g

Peach 7.jpgPeach 7.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53567-076053567-0760-1, 53567-0760-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PERBORATE TETRAHYDRATE822HSQ655RIACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
CALCIUM PEROXIDE7FRO2ENO91IACT
SORBITOL506T60A25RIACT
CALCIUM CARBONATEH0G9379FGKIACT
STARCH, CORNO8232NY3SJIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM CARBONATE0E53J927NAIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
8631f27c-9a8f-edb7-e053-2a91aa0a79788631f27c-9a8e-edb7-e053-2a91aa0a79782019-04-15WarningsExact identifier
spl id: 8631f27c-9a8f-edb7-e053-2a91aa0a7978
spl set id: 8631f27c-9a8e-edb7-e053-2a91aa0a7978

Reported adverse events (FAERS/openFDA)#

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