Oral Defense Fluoride Rinse
NDC 52644-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52644-002?
  5. Oral Defense Fluoride Rinse Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

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

Oral Defense Fluoride Rinse is a OTC MONOGRAPH FINAL-approved product labeled by Oral Defense, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a turquoise product. This product entry covers the primary NDC 52644-002 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
52644-002
Proprietary Name:
Oral Defense Fluoride Rinse
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Oral Defense, Llc
Labeler Code:
52644
Product Label ID:
59a1f399-3609-4eef-b635-1f526cd75819
FDA Application Number: [6]
part355
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
08-31-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
TURQUOISE (C48334 - BLUE GREEN)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 52644-002?

The NDC code 52644-002 is assigned by the FDA to the product Oral Defense Fluoride Rinse. This pharmaceutical product is labeled by Oral Defense, Llc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 52644-002-00, 52644-002-02. 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?

Adults and children 6 years of age and olderUse once a day, preferably before bedtime, after brushing and flossing thoroughly.For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow.Supervise children over 6 years of age until capable of suing without supervision.Consult with a dentist or doctor for use with children under 6 years of age.Do not take in food or drink for 30 minutes after application.

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".