Breathrx With Zytex

Cetylpyridinium Chloride,sodium Fluoride

Discus Dental, Llc
Human Otc Drug
NDC 64854-044

Breathrx With Zytex also known as Cetylpyridinium Chloride,sodium Fluoride is a human otc drug labeled by 'Discus Dental, Llc'. National Drug Code (NDC) number for Breathrx With Zytex is 64854-044. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Breathrx With Zytex drug includes . The currest status of Breathrx With Zytex drug is Active.

Drug Information:

Drug NDC:	64854-044
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Breathrx With Zytex
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Cetylpyridinium Chloride,sodium Fluoride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Discus Dental, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	DENTAL ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	18 Sep, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	06 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part356,part355
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Discus Dental, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	891775 1599135 2104586
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
64854-044-01	1 KIT in 1 PACKAGE (64854-044-01) * 59 mL in 1 BOTTLE, PLASTIC (64854-012-01) * 112 g in 1 TUBE (64854-018-01) * 237 mL in 1 BOTTLE, PLASTIC (64854-014-11)	18 Sep, 2014	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Breathrx With Zytex

Cetylpyridinium Chloride,sodium Fluoride

Kit
Discus Dental, LLC
NDC: 64854-032

Breathrx With Zytex

Cetylpyridinium Chloride,sodium Fluoride

Kit
Discus Dental, LLC
NDC: 64854-044

Purpose:

Purpose anticavity

Purpose antibacterial

Purpose antibacterial, antiplaque, antigingivitis

Product Elements:

Breathrx with zytex cetylpyridinium chloride,sodium fluoride breathrx with zytex cetylpyridinium chloride anhydrous citric acid cetylpyridinium chloride cetylpyridinium xylitol sorbitol mint peg-40 castor oil fd&c blue no. 1 poloxamer 407 eucalyptus oil water zinc gluconate saccharin sodium saccharin cocamidopropyl betaine propylene glycol thymol light blue breathrx with zytex cetylpyridinium chloride cetylpyridinium chloride cetylpyridinium peppermint oil peppermint peg-40 castor oil fd&c blue no. 1 peg-12 dimethicone water zinc gluconate saccharin sodium saccharin propylene glycol thymol eucalyptus oil light blue breathrx with zytex sodium fluoride silicon dioxide titanium dioxide sodium fluoride fluoride ion xylitol sorbitol mint carboxymethylcellulose fd&c blue no. 1 polyethylene glycol 600 water mica zinc gluconate saccharin sodium saccharin glycerin thymol eucalyptus oil sodium pyrophosphate sodium lauryl sulfate xanthan gum sodium methyl cocoyl taurate potassium pyrophosphate blue with sparkles

Indications and Usage:

Use aids in the prevention of dental cavities

Use helps fight odor-causing bacteria

Use helps prevent plaque that leads to gingivitis helps fight odor-causing bacteria

Warnings:

Warnings if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Warnings do not use if seal is broken.

Warnings if more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center right away. stop use an ask a dentist if: gingivitis, bleeding, or redness persists for more than 2 weeks; you have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between teeth. these may be signs or symptoms of periodontitis, a serious form of gum disease.

Do not use products if seals are broken or missing.

Dosage and Administration:

Directions do not swallow rinse. supervise children as necessary until capable of using without supervision. 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 doctor. children 2 years to 6 years instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). children under 2 years of age consult a dentist or doctor.

Directions shake before use adults and children 12 years of age and older spray 2-3 times on the back of the tongue and gently scape with cleaner children 6 - 12 years of age supervise use children under 6 years do not use

Directions do not swallow rinse. adults and children 12 years of age and older vigorously swish 1/2 oz. (20 ml) of rinse, twice a day, for 30 seconds then spit out children 6 years to under 12 years supervise use children under 6 years do not use

Package Label Principal Display Panel:

Package label carton - front carton - back

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.