Ortho Guard Gel, Dentifrice
NDC 63783-403

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63783-403?
  5. Ortho Guard Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

Ortho Guard (sodium fluoride) is a OTC MONOGRAPH DRUG-approved product labeled by Massco Dental A Division Of Dunagin Pharmaceuticals. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a gel, dentifrice for oral administration. This product entry covers the primary NDC 63783-403 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63783-403
Proprietary Name:
Ortho Guard
Non-Proprietary Name: [1]
Sodium Fluoride
Substance Name: [2]
Sodium Fluoride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Massco Dental A Division Of Dunagin Pharmaceuticals
Labeler Code:
63783
Product Label ID:
8d3e0dd0-b584-413b-adf3-5c2d05ab72dd
FDA Application Number: [6]
M021
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
01-01-1989
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 63783-403?

The NDC code 63783-403 is assigned by the FDA to the product Ortho Guard. It is commonly known by its generic name, sodium fluoride. This pharmaceutical product is labeled by Massco Dental A Division Of Dunagin Pharmaceuticals and is currently categorized as listed product. The medication is a gel, dentifrice administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63783-403-16. 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 AND OLDERUSE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING. CHILDREN UNDER 6CONSULT A DENTIST OR PHYSICIAN

What are Active Ingredients of this product?

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.

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:

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Product & Regulatory Definitions
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.
What is the Substance Name? 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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".