Ortho Guard
Sodium Fluoride
Massco Dental A Division Of Dunagin Pharmaceuticals
Human Otc Drug
NDC 63783-400Ortho Guard also known as Sodium Fluoride is a human otc drug labeled by 'Massco Dental A Division Of Dunagin Pharmaceuticals'. National Drug Code (NDC) number for Ortho Guard is 63783-400. This drug is available in dosage form of Gel, Dentifrice. The names of the active, medicinal ingredients in Ortho Guard drug includes Sodium Fluoride - 4.4 mg/10mL . The currest status of Ortho Guard drug is Active.
Drug Information:
| Drug NDC: | 63783-400 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ortho Guard |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Massco Dental A Division Of Dunagin Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel, Dentifrice |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM FLUORIDE - 4.4 mg/10mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jan, 1989 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part355 |
| 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. |
| Listing Expiration Date: | 15 Jan, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Massco Dental A Division of Dunagin Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 8ZYQ1474W7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63783-400-16 | 473 mL in 1 BOTTLE (63783-400-16) | 01 Jan, 1989 | 31 Dec, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose anticavity
Product Elements:
Ortho guard sodium fluoride sodium fluoride fluoride ion sodium phosphate, monobasic, monohydrate sodium benzoate saccharin sodium icy cool mint ortho guard sodium fluoride sodium fluoride fluoride ion water sodium phosphate, monobasic, monohydrate sodium benzoate saccharin sodium grape ortho guard sodium fluoride sodium fluoride fluoride ion water sodium phosphate, monobasic, monohydrate sodium benzoate saccharin sodium orange ortho guard sodium fluoride sodium fluoride fluoride ion water sodium phosphate, monobasic, monohydrate sodium benzoate saccharin sodium strawberry
Indications and Usage:
Use aids in the prevention of dental decay
Warnings:
Warnings when using this product, do not swallow unless to do so by a dentist or physician. if more solution is accidentally swallowed than used for rinsing, get medical help or contact a poison control center immediately.
General Precautions:
Other information store at room temperature.
Dosage and Administration:
Directions: use as directed adults and children 6 years and older use 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 6 consult a dentist or physician
Package Label Principal Display Panel:
Package label orthoguard anti-cavity fluoride rinse 0.044% sodium fluoride in an acidulated phosphate topical solution. manufactured by massco dental a division of dunagin pharmaceuticals, gravette ar (479) 787-5168. www.masscodental.net res ortho mint ortho orange ortho strawberry ortho grape
Further Questions:
Questions? comments? call 1-479-787-5168 m-f 9 am to 5pm cst