Sodium Fluoride
Method Pharmaceuticals, Llc
Human Prescription Drug
NDC 58657-322Sodium Fluoride is a human prescription drug labeled by 'Method Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Fluoride is 58657-322. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Sodium Fluoride drug includes Sodium Fluoride - .5 mg/mL . The currest status of Sodium Fluoride drug is Active.
Drug Information:
| Drug NDC: | 58657-322 |
| 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: | Sodium Fluoride |
| 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: | Method Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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 - .5 mg/mL
|
| 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: | 15 Aug, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 Dec, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Method Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 315102
|
| 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 |
|---|
| 58657-322-50 | 50 mL in 1 BOTTLE, DROPPER (58657-322-50) | 15 Aug, 2018 | N/A | 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. |
Product Elements:
Sodium fluoride sodium fluoride glycerin methylparaben propylene glycol water sodium benzoate sucralose sodium fluoride fluoride ion
Indications and Usage:
Indications and usage as a supplemental source of fluoride. it has been established that ingestion of fluoridated drinking water (1 ppm f) during the period of tooth development results in significant decrease in the incidence of dental caries.1 sodium fluoride drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm f.
Warnings:
Warnings prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. read directions carefully before using. keep out of the reach of infants and children.
Contraindications:
Contraindications do not use in areas where drinking water exceeds 0.6 ppm f. do not administer to pediatric patients less than 6 months old.
Adverse Reactions:
Adverse reactions allergic rash and other idiosyncrasies have been rarely reported. to report suspected adverse reactions, contact the fda at 1-800-fda-1088 or method pharmaceuticals, llc at 877-250-3427. store at controlled room temperature 15° to 30°c (59° to 86°f).
Description:
Description each ml of sodium fluoride drops contains 0.5 mg fluoride ion (f) from 1.1 mg sodium fluoride (naf). for use as a dental caries preventive in pediatric patients. sugar free, alcohol free, dye free and gluten free. supplement facts serving size: 1 ml servings per container: 50 amount per serving % daily value fluoride (as sodium fluoride) 0.5 mg ** ** daily value not established. active ingredients: sodium fluoride (0.11% w/v). other ingredients: glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose. fluoride supplement dosage schedules age fluoride ion level in drinking water (ppm)* < 0.3 ppm 0.3 - 0.6 ppm > 0.6 ppm birth to 6 months none none none 6 months to 3 years half dropperful 0.25 mg f (1/2 ml) none none 3 to 6 years one dropperful 0.5 mg f (1 ml)â half dropperful 0.25 mg f (1/2 ml) none 6 to 16 years two dropperfuls 1 mg f (2 ml) one dropperful 0.5 mg f (1 ml) none * 1.0 ppm = 1 mg/liter â 1.1 mg sodium fluoride contains 0.5 mg fluoride ion fluoride supplement dose schedule approved by the american dental association, american academy of pediatrics and american academy of pediatric dentistry. keep this and all medications out of the reach of children.
Clinical Pharmacology:
Clinical pharmacology sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization and by inhibiting the cariogenic microbial process.
How Supplied:
How supplied 50 ml bottles (58657-322-50)
Package Label Principal Display Panel:
Principal display panel ndc 58657-322-50 sodium fluoride drops sodium fluoride oral solution, usp 0.5 mg/ml grape flavored 1.69 fl. oz. (50 ml) principal display panel ndc 58657-322-50 sodium fluoride drops sodium fluoride oral solution, usp 0.5 mg/ml grape flavored 1.69 fl. oz. (50 ml)