Sodium Fluoride Chewable
Sodium Fluoride
Method Pharmaceuticals, Llc
Human Prescription Drug
NDC 58657-162Sodium Fluoride Chewable also known as Sodium Fluoride is a human prescription drug labeled by 'Method Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Fluoride Chewable is 58657-162. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sodium Fluoride Chewable drug includes Sodium Fluoride - 1 mg/1 . The currest status of Sodium Fluoride Chewable drug is Active.
Drug Information:
| Drug NDC: | 58657-162 |
| 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 Chewable |
| 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: | Tablet |
| 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 mg/1
|
| 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: | 17 Aug, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Jan, 2026 |
| 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: | 198215
313036
315213
|
| 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. |
| UPC: | 0358657162122
0358657160128
0358657161125
0358657161101
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 58657-162-12 | 120 TABLET in 1 BOTTLE (58657-162-12) | 17 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 chewable sodium fluoride citric acid monohydrate magnesium stearate malic acid microcrystalline cellulose sucralose talc xylitol sodium fluoride fluoride ion white to off white m160 sodium fluoride chewable sodium fluoride citric acid monohydrate magnesium stearate malic acid microcrystalline cellulose sucralose talc xylitol sodium fluoride fluoride ion m161 sodium fluoride chewable sodium fluoride citric acid monohydrate magnesium stearate malic acid microcrystalline cellulose sucralose talc xylitol sodium fluoride fluoride ion m162
Indications and Usage:
Indications and usage for once daily self-applied systemic use as a dental caries preventive in pediatric patients. it has been established that ingestion of fluoridated drinking water (1 ppm f¯) during the period of tooth development results in a significant decrease in the incidence of dental caries. sodium fluoride chewable tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm f¯.
Warnings:
Warning 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. this product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking. keep out of the reach of infants and children.
General Precautions:
General please refer to the contraindications , warnings and overdosage sections for overdosage concerns. use in pediatric patients below the age of 3 years is not recommended by current american dental associations and american academy of pediatrics guidelines.
Dosage and Administration:
Dosage and administration (for dosage see table) dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. see schedule below to determine dosage.
Contraindications:
Contraindications fluoride 1.0 mg tablets are contraindicated when the fluoride content of drinking water is >0.3 ppm f¯ and should not be administered to pediatric patients under 6 years. fluoride 0.5 mg tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm f¯ and should not be administered to pediatric patients under age 6 when the fluoride content of drinking water is 0.3 ppm f¯ or more or to pediatric patients under age 3 years. fluoride 0.25 mg tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm f¯ and should not be administered to pediatric patients under age 3 years when the fluoride content of drinking water is 0.3 ppm f¯ or more. do not administer sodium fluoride chewable tablets (any strength) to pediatric patients under age 3 years. sodium fluoride chewable tablets (any strength) are not indicated for use in adults.
Adverse Reactions:
Adverse reactions allergic rash and other idiosyncrasies have been rarely reported.
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Pediatric Use:
Pediatric use the use of sodium fluoride chewable tablets as a caries preventive in pediatric age groups 3 years to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.
Geriatric Use:
Geriatric use sodium fluoride chewable tablets (any strength) are not indicated for use in geriatric patients.
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility in a study conducted in rodents, no carcinogenesis was found in male and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 and 4.1 mg/kg of body weight. in a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. this dose is at least 400 times greater than the recommended daily dose of sodium fluoride chewable tablets. fluoride ion is not mutagenic in standard bacterial systems. it has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodentcells at does much higher than those to which humans are exposed. in vivo data is conflicting. some studies report chromosome damage in rodents while other studies using similar protocols report negative results. potential adverse reproductive effects of
Read more...fluoride exposure in humans has not been adequately evaluated. adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. this dose is approximately 200 times greater than the recommended daily dose of sodium fluoride chewable tablets.
How Supplied:
How supplied each tablet contains 0.25 mg fluoride from 0.55 mg sodium fluoride. white to off-white, orange flavor, round-shaped chewable tablet. debossed with "m160" on one side. ndc 58657-160-12 (120 count). each tablet contains 0.5 mg fluoride from 1.1 mg sodium fluoride. white to off-white, orange flavor, round-shaped chewable tablet. debossed with "m161" on one side. ndc 58657-161-12 (120 count). ndc 58657-161-10 (1,000 count). each tablet contains 1.0 mg fluoride from 2.2 mg sodium fluoride. white to off-white, orange flavor, round-shaped chewable tablet. debossed with "m162" on one side. ndc 58657-162-12 (120 count).
Package Label Principal Display Panel:
Principal display panel ndc 58657-160-12 sodium fluoride chewable tablets 0.25 mg 120 tablets rx only principal display panel ndc 58657-160-12 sodium fluoride chewable tablets 0.25 mg 120 tablets rx only
Principal display panel ndc 58657-161-12 sodium fluoride chewable tablets 0.5 mg 120 tablets rx only principal display panel ndc 58657-161-12 sodium fluoride chewable tablets 0.5 mg 120 tablets rx only
Principal display panel ndc 58657-161-10 sodium fluoride chewable tablets 0.5 mg 1000 tablets rx only principal display panel ndc 58657-161-10 sodium fluoride chewable tablets 0.5 mg 1000 tablets rx only
Principal display panel ndc 58657-162-12 sodium fluoride chewable tablets 1.0 mg (from 2.2 mg sodium fluoride) 120 tablets rx only principal display panel ndc 58657-162-12 sodium fluoride chewable tablets 1.0 mg (from 2.2 mg sodium fluoride) 120 tablets rx only