NDC 65517-2017 Dawnmist Fluoride

Sodium Fluoride

NDC Product Code 65517-2017

NDC 65517-2017-0

Package Description: 78 g in 1 TUBE

NDC 65517-2017-1

Package Description: 17 g in 1 TUBE

NDC 65517-2017-2

Package Description: 24 g in 1 TUBE

NDC 65517-2017-3

Package Description: 43 g in 1 TUBE

NDC Product Information

Dawnmist Fluoride with NDC 65517-2017 is a a human over the counter drug product labeled by Dukal Corporation. The generic name of Dawnmist Fluoride is sodium fluoride. The product's dosage form is paste and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 245598.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Dawnmist Fluoride 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.


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)
  • SORBITOL (UNII: 506T60A25R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: Dukal Corporation
Labeler Code: 65517
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: 01-17-2014 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

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Dawnmist Fluoride Product Label Images

Dawnmist Fluoride 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 Fluoride 0.22%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Keep Out Of Reach Of Children Under 6 Years Of Age

If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 years: To minimize swallowing, use a peas sized amount and supervisor brushing until good habits are established. Children under 2 years: Ask a dentist or physician

Inactive Ingredient

Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin

Label Image

DawnMist Gel Fluoride Toothpaste 78g (65517-2017-0)DawnMist Gel Fluoride Toothpaste 17g (65517-2017-1)DawnMist Gel Fluoride Toothpaste 24g (65517-2017-2)DawnMist Gel Fluoride Toothpaste 43g (65517-2017-3)Manufactured for:DUKAL CORPORATIONRonkonkoma, NY 11779(631) 656-3800Made in IndiaMM1.jpg

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