NDC 53567-0760 Supersmile

Sodium Monofluorophosphate

NDC Product Code 53567-0760

NDC 53567-0760-1

Package Description: 198.5 g in 1 TUBE

NDC 53567-0760-2

Package Description: 70.8 g in 1 TUBE

NDC Product Information

Supersmile with NDC 53567-0760 is a a human over the counter drug product labeled by Robell Research, Inc.. The generic name of Supersmile is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental; oral form.

Labeler Name: Robell Research, Inc.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Supersmile Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • WATER (UNII: 059QF0KO0R)
  • CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
  • SORBITOL (UNII: 506T60A25R)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MAGNESIUM CARBONATE (UNII: 0E53J927NA)
  • SACCHARIN (UNII: FST467XS7D)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Robell Research, Inc.
Labeler Code: 53567
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Supersmile Product Label Images

Supersmile Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient:

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

Purpose:

Anticavity.

Uses:

Aids in the prevention of cavities.

Warnings:

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

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:

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:

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

Supersmile®extra whitelotus peach minteaprofessionalextrawhiteningtoothpasteContains Fluoride7 oz / 198.5 g

* Please review the disclaimer below.

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