NDC 72863-101 Himalayan Pink Salt Sweet Herbal Mint

Sodium Fluoride, Sodium Monofluorophosphate

NDC Product Code 72863-101

NDC Code: 72863-101

Proprietary Name: Himalayan Pink Salt Sweet Herbal Mint Additional informationCallout TooltipWhat 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 Fluoride, Sodium Monofluorophosphate Additional informationCallout TooltipWhat 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.


Code Structure
  • 72863 - Rael, Inc.
    • 72863-101 - Himalayan Pink Salt Sweet Herbal Mint

NDC 72863-101-02

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 300 g in 1 BOTTLE, PUMP (72863-101-01)

NDC Product Information

Himalayan Pink Salt Sweet Herbal Mint with NDC 72863-101 is a a human over the counter drug product labeled by Rael, Inc.. The generic name of Himalayan Pink Salt Sweet Herbal Mint is sodium fluoride, sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Rael, 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 Additional informationCallout TooltipWhat 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.


Himalayan Pink Salt Sweet Herbal Mint Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1.92 g/300g
  • SODIUM FLUORIDE .09 g/300g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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 PYROPHOSPHATE (UNII: O352864B8Z)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rael, Inc.
Labeler Code: 72863
FDA Application Number: part355 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-27-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Himalayan Pink Salt Sweet Herbal Mint Product Label Images

Himalayan Pink Salt Sweet Herbal Mint 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 FluorideSodium monofluorophosphate

Keep Out Of Reach Of Children Under 6 Years Of Age.

Keep out of reach of children under 6 years of age.

Purpose

Anticavity

Uses

Helps protect against cavities

Warnings

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

Directions

Adults and children 6 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.Children 2 to 6 yearsUse only a pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing).Children under 2 yearsAsk a dentist or physician

Inactive Ingredients

Silicon dioxide, Sodium pyrophosphate, Glycerin, Xanthan gum, Poloxamer407, Sodium polyacrylate, Sodium lauryl sulfate, sodium saccharin, Titanium dioxide, Ferric Oxide, Sodium chloride, Bamboo salit, Himalayan pink salt, Green Tea Extract, Scutellaria baicalensis root extract, Chamomile Extract, Licorice extract, Calendula extract, L-Menthol, Herbal mint flavor, Purified water.​

* Please review the disclaimer below.

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