FDA.reportPublic FDA data

Supersmile

Manufacturer
Robell Research, Inc.
Effective date
2023-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:26:21

Label at a glance#

ProductSupersmile
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 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 about 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 Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years old. If more than used for brushing is accidentally 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. Instruct children under 6 years of age about 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.

Ingredients:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

supersmile extra white

refreshmint

professional

extra

whitening

toothpaste

contains fluoride

Net wt. 7 oz / 198.5g

refresh_mint_image.jpgrefresh_mint_image.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
53567-077753567-0777-1, 53567-0777-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CALCIUM PEROXIDE7FRO2ENO91IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
MINTFV98Z8GITPIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MAGNESIUM CARBONATE0E53J927NAIACT
SODIUM PERBORATE TETRAHYDRATE822HSQ655RIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
04381812-d9ad-3583-e063-6294a90a2c6804381812-d9ac-3583-e063-6294a90a2c682023-08-31Exact identifier
spl id: 04381812-d9ad-3583-e063-6294a90a2c68
spl set id: 04381812-d9ac-3583-e063-6294a90a2c68

Reported adverse events (FAERS/openFDA)#

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