Neutramaxx 5000 Tcp
Sodium Fluoride
Massco Dental A Division Of Dunagin Pharmaceuticals
Human Prescription Drug
NDC 63783-501Neutramaxx 5000 Tcp also known as Sodium Fluoride is a human prescription drug labeled by 'Massco Dental A Division Of Dunagin Pharmaceuticals'. National Drug Code (NDC) number for Neutramaxx 5000 Tcp is 63783-501. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Neutramaxx 5000 Tcp drug includes Sodium Fluoride - 1.1 g/112g . The currest status of Neutramaxx 5000 Tcp drug is Active.
Drug Information:
| Drug NDC: | 63783-501 |
| 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: | Neutramaxx 5000 Tcp |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Paste, 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 - 1.1 g/112g
|
| 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: | UNAPPROVED DRUG OTHER |
| 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 Aug, 2011 |
| 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. |
| Listing Expiration Date: | 19 Jun, 2026 |
| 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. |
| RxCUI: | 392038
1191716
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| 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 |
|---|
| 63783-501-04 | 112 g in 1 TUBE (63783-501-04) | 01 Aug, 2011 | 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 section for prevention of tooth decay, orthodontic decalcification and hypersensitivity.
Product Elements:
Neutramaxx 5000 tcp sodium fluoride sodium fluoride fluoride ion water sorbitol hydrated silica polyethylene glycol 8000 carboxymethylcellulose xylitol sodium phosphate, monobasic, monohydrate titanium dioxide saccharin sodium tribasic calcium phosphate refreshing mint flavor
Indications and Usage:
Indications and usage section neutramaxxtm 5000 with tri-calcium phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity
Warnings:
Warning section warnings do not swallow for topical use only
Dosage and Administration:
Directions: use as directed section this prescription dentifrice is recommended for adults and pediatric patients 6 years and older apply a thin ribbon of neutramaxxtm 5000 tcp along the length of the toothbrush no more than "pea size" total dose. brush for two minutes. after brushing adults - expectorate, do not eat for 30 minutes. children 6 years of age or older - expectorate and rinse mouth with water. use at bedtime in place of your regular toothpaste or as directed by your dental professional.
Package Label Principal Display Panel:
Package label refreshing mint flavor relieves sensitivity anti-cavity toothpaste neutramaxx tm 5000 tcp xylito1.1% neutral sodium fluoride 5000 ppm sweetened with xylitol does not contain sodium lauryl sulfate rx only net wt. 4 oz (112 g) manufactured by: massco dental a division of dunagin pharmaceuticals, gravette, ar (479) 787-5168 www.masscodental.net res massco__tcp1_label
Further Questions:
Questions? comments? section call 1-479-787-5168 m-f 9am to 5 pm cst