NDC 53942-299 Antispetic
Cetylpyridinium Chloride Liquid Oral

Product Information

What is NDC 53942-299?

The NDC code 53942-299 is assigned by the FDA to the product Antispetic which is a human over the counter drug product labeled by Demoulas Super Markets. The generic name of Antispetic is cetylpyridinium chloride. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 53942-299-86 1000 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code53942-299
Proprietary Name 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.
Antispetic
Non-Proprietary Name 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.
Cetylpyridinium Chloride
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Demoulas Super Markets
Labeler Code53942
FDA Application Number 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.
part356
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-21-2012
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Antispetic?


Product Packages

NDC Code 53942-299-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

Product Details

What are Antispetic Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CETYLPYRIDINIUM CHLORIDE .7 mg/mL - Cationic bactericidal surfactant used as a topical antiseptic for skin, wounds, mucous membranes, instruments, etc.; and also as a component in mouthwash and lozenges.

Antispetic Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Antispetic Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Antispetic Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Claims



For better oral hygiene and fresher breath.


Active Ingredient



Cetylpyridinium chloride 0.07%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



for this product


Stop Use And Ask A Dentist If



  • gingivitis, gleeding or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or smptoms of periodontitis, a serious form of gum disease

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



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


Directions



  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other Information



  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients



water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, methylparaben, sucralose, propylparaben, blue1


Disclaimer



This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Rinse


Adverse Reaction



DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876


Principal Display Panel



MORE FOR YOUR DOLLAR

MARKET BASKET

Sealed with printed

neckband for your protection

Compare to active ingredient in Crest Pro-Health Rinse

Mulit-Action

Alcohol-Free

Antiseptic

Oral Rinse

with CPC

Antigingivitis/Antiplaque

  • KILLS GERMS
  • HELPS PREVENT PLAQUE
  • HELPS PREVENT GINGIVITIS
  • HELPS KEEP TEETH FEELING CLEAN
  • FRESHENS BREATH
  • NO BURN OF ALCOHOL
  • Zesty Mint

    1 L (33.8 FL OZ)


* Please review the disclaimer below.