NDC 53462-504 Qcare Oral Cleansing And Suctioning System, Q4

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

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

Get all the details for National Drug Code (NDC) 53462-504 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
53462-504
Proprietary Name:
Qcare Oral Cleansing And Suctioning System, Q4
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
53462
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.
Start Marketing Date: [9]
05-21-1998
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 53462-504?

The NDC code 53462-504 is assigned by the FDA to the product Qcare Oral Cleansing And Suctioning System, Q4 which is product labeled by Sage Products Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53462-504-60 1 kit in 1 kit * 1 packet in 1 package / 2 pouch in 1 packet / 7 ml in 1 pouch * 1 packet in 1 package / 2 pouch in 1 packet / 7 ml in 1 pouch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Qcare Oral Cleansing And Suctioning System, Q4?

Suction Swab with Perox-A-Mint Solution:Before opening, turn package over, burst solution packet with thumbs.Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.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.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.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.Suction Toothbrush with Antiplaque Solution:Before opening, turn package over, burst solution packet with thumbs.Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.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.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.Children ages 6 to 12 years: supervise use.Children under 6 years of age: do not use.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.

Which are Qcare Oral Cleansing And Suctioning System, Q4 UNII Codes?

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

Which are Qcare Oral Cleansing And Suctioning System, Q4 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. The UNII codes for the inactive ingredients in this product are:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".