Qcare Oral Cleansing And Suctioning System
NDC 53462-464

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 53462-464?
  4. Qcare Oral Cleansing And Suctioning System Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Qcare Oral Cleansing And Suctioning System is a OTC MONOGRAPH NOT FINAL-approved product labeled by Sage Products Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 53462-464 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53462-464
Proprietary Name:
Qcare Oral Cleansing And Suctioning System
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Sage Products Llc
Labeler Code:
53462
Product Label ID:
08560105-d7fc-334e-08a1-73c0f1f93b7b
FDA Application Number: [6]
part356
Marketing Category: [8]
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.

Marketing Timeline

Start Marketing Date: [9]
01-11-2016
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 53462-464?

The NDC code 53462-464 is assigned by the FDA to the product Qcare Oral Cleansing And Suctioning System. This pharmaceutical product is labeled by Sage Products Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 53462-464-60. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Toothette Oral Care Suction ToothbrushBefore opening, turn package over, burst solution packet with thumbs.Peel lid to open.Attach Toothbrush to suction line.Clean teeth and oral cavity for approximately one minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Toothbrush. Reattach Covered Yankauer to suction line.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity.Toothette Oral Care Suction SwabBefore opening, turn package over, burst solution packet with thumbs.Peel lid to open.Attach Suction Swab to suction line.Clean teeth and oral cavity for approximately one minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Suction Swab. Reattach Covered Yankauer to suction line.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity.Oropharyngeal Suction Catheter Non-sterilePeel lid to open.Attach Suction Catheter to suction line.Suction secretions from the oropharyngeal cavity.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard Suction Catheter. Reattach Covered Yankaurer to suction line.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".