NDC 76884-0005 Dr. Daddys Kids Toothtoothpaste(raspberry Flavor)

Dental Type Silica, Tetrasodium Pyrophosphate, Sodium Monofluorophosphate

NDC Product Code 76884-0005

NDC CODE: 76884-0005

Proprietary Name: Dr. Daddys Kids Toothtoothpaste(raspberry Flavor) 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: Dental Type Silica, Tetrasodium Pyrophosphate, 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

  • 76884 - Tb Healthcare Co., Ltd.
    • 76884-0005 - Dr. Daddys Kids Toothtoothpaste(raspberry Flavor)

NDC 76884-0005-1

Package Description: 60 g in 1 TUBE

NDC Product Information

Dr. Daddys Kids Toothtoothpaste(raspberry Flavor) with NDC 76884-0005 is a a human over the counter drug product labeled by Tb Healthcare Co., Ltd.. The generic name of Dr. Daddys Kids Toothtoothpaste(raspberry Flavor) is dental type silica, tetrasodium pyrophosphate, sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form.

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.

Dr. Daddys Kids Toothtoothpaste(raspberry Flavor) 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.

  • XYLITOL (UNII: VCQ006KQ1E)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)

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: Tb Healthcare Co., Ltd.
Labeler Code: 76884
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: 09-20-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Dr. Daddys Kids Toothtoothpaste(raspberry Flavor) Product Label Images

Dr. Daddys Kids Toothtoothpaste(raspberry Flavor) 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

Otc - Active Ingredient

Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate), Sodium Monofluorophosphate

Inactive Ingredient

D-Sorbitol Solution, Concentrated Glycerin, Xanthangum, Sodium Cocoyl Glutamate, Ascorbic Acid, Hydroxyapatite, Xylitol, Sodium Chloride, Green Tea Extract, Eucalyptus Extract, Matricaria Extract, Aloe Extract, Sage Extract, Grapefruit Seed Extract, natural raspberry flavor, Water

Otc - Purpose

ANTI-CAVITY

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Put an appropriate amount on a toothbrush and brush teeth.

Warnings

Storage method1. Keep it at room temperature in a classified container. 2. Cover and store at room temperature. 3. Store in a not moisture and cool place. 4. Air may come out during use of this product, but there is no problem with its weight.Usage Precautions1. Be careful not to swallow. Rinse mouth thoroughly after use2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.5. Keep out of the reach of children under 6 years of age.

Dosage & Administration

For dental use only

* Please review the disclaimer below.