NDC 72916-110 Schmidts Wondermint Tooth And Mouth

Sodium Monofluorophosphate

NDC Product Code 72916-110

NDC Code: 72916-110

Proprietary Name: Schmidts Wondermint Tooth And Mouth What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Monofluorophosphate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72916 - Schmidt's Naturals
    • 72916-110 - Schmidts

NDC 72916-110-05

Package Description: 1 TUBE in 1 CARTON > 133 g in 1 TUBE

NDC Product Information

Schmidts Wondermint Tooth And Mouth with NDC 72916-110 is a a human over the counter drug product labeled by Schmidt's Naturals. The generic name of Schmidts Wondermint Tooth And Mouth is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Schmidt's Naturals

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.

Schmidts Wondermint Tooth And Mouth 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 1.079 g/133g

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNOLIA ACUMINATA BARK (UNII: 2U55IJZ60C)
  • LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
  • POMEGRANATE SEED (UNII: 7294Z34NS7)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • UBIDECARENONE (UNII: EJ27X76M46)
  • ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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.

Product Labeler Information

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

Labeler Name: Schmidt's Naturals
Labeler Code: 72916
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: 06-20-2019 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.

Schmidts Wondermint Tooth And Mouth Product Label Images

Schmidts Wondermint Tooth And Mouth 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 0.81%(0.10% w/v Fluoride Ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 Physician.Children 2 to 6 years of age:Instruct children under 6 years of age in good brushing and rinsing methods (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a Dentist or Physician.

Inactive Ingredients

Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Natural Flavor, Sodium Methyl Cocoyl Taurate, Xanthan Gum, Magnolia Acuminata (Magnolia Bark) Extract, Lycium Barbarum (Goji Berry) Extract, Punica Granatum (Pomegranate) Seed Extract, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Mixed Tocopherols (Sunflower-derived), Stevia Rebaudiana Leaf/Stem Extract, Sodium Bicarbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Coenzyme Q10, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate.

Questions:

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* Please review the disclaimer below.

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