NDC 36800-004 Anticavity Fluoride Rinse

Sodium Fluoride

NDC Product Code 36800-004

NDC CODE: 36800-004

Proprietary Name: Anticavity Fluoride Rinse 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 Fluoride 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.

Product Characteristics

Flavor(s):
BUBBLE GUM (C73368 - BUBBLE GUM FLAVOR)

NDC Code Structure

  • 36800 - Topco Associates Llc

NDC 36800-004-44

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Anticavity Fluoride Rinse with NDC 36800-004 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Anticavity Fluoride Rinse is sodium fluoride. The product's dosage form is rinse and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 240698.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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.

Anticavity Fluoride Rinse 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • SORBITOL (UNII: 506T60A25R)

Administration Route(s)

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

  • 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: Topco Associates Llc
Labeler Code: 36800
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: 04-08-2004 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.

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]

* Please review the disclaimer below.

Anticavity Fluoride Rinse Product Label Images

Anticavity Fluoride Rinse 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

Active ingredientsSodium fluoride 0.05% (0.02% w/v fluoride ion)

Otc - Purpose

PurposeAnticavity rinse

Indications & Usage

Use aids in the prevention of dental cavities

Warnings

Warning

Otc - Keep Out Of Reach Of Children

Enter section text here

Dosage & Administration

Directions• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste•

remove cap• pour 10 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark 



vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out• do not swallow the rinse•

do not eat or drink for 30 minutes after rinsing 

• instruct children under 12 years of age in good rinsing habits ( to minimize swallowing)• do not swallow the rinse • do not eat or drink for 30 minutes after rinsing•

instruct children under 12  years of age in good rinsing habits ( to minimize swallowing) 

• supervise children as necessary until capable of using without supervision• 

children under 6 years of age: consult a dentist or doctor

Storage And Handling

Other information • store at room temperature

Inactive Ingredient

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride rinse.

Adverse Reactions

Distributed by: TOPCO ASSOCIATES LLC7711 GROSS POINT ROAD, SKOKIE, IL 60077QUESTIONS? 1-888-423-0139

* Please review the disclaimer below.