Tidalove Smile More Oral Care
Sodium Fluoride Tablet
Paranmare
Human Otc Drug
NDC 82756-002Tidalove Smile More Oral Care also known as Sodium Fluoride Tablet is a human otc drug labeled by 'Paranmare'. National Drug Code (NDC) number for Tidalove Smile More Oral Care is 82756-002. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Tidalove Smile More Oral Care drug includes Sodium Fluoride - .7 mg/1.54mg . The currest status of Tidalove Smile More Oral Care drug is Active.
Drug Information:
| Drug NDC: | 82756-002 |
| 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: | Tidalove Smile More Oral Care |
| 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 Tablet |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Paranmare |
| 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 - .7 mg/1.54mg
|
| 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 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| 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: | 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: | Paranmare
|
| 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 |
|---|
| 82756-002-11 | 1.54 mg in 1 BAG (82756-002-11) | 10 Jun, 2022 | 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. |
Purpose:
Aids in the prevention of dental cavities
Product Elements:
Tidalove smile more oral care sodium fluoride tablet pyridoxine hydrochloride sorbitol eucalyptus oil silicon dioxide sodium pyrophosphate xylitol rosemary sea salt hydroxypropyl cellulose, unspecified sodium cocoyl glutamate sodium bicarbonate .alpha.-tocopherol acetate menthol, unspecified form microcrystalline cellulose xanthan gum magnesium stearate sodium ascorbate green tea leaf sodium fluoride fluoride ion none tidalove smile more oral care sodium fluoride tablet pyridoxine hydrochloride .alpha.-tocopherol acetate sodium ascorbate silicon dioxide sodium pyrophosphate magnesium stearate xylitol xanthan gum sodium cocoyl glutamate sorbitol sodium fluoride fluoride ion microcrystalline cellulose sea salt hydroxypropyl cellulose, unspecified eucalyptus oil sodium bicarbonate menthol, unspecified form green tea leaf none
Indications and Usage:
Adults and children 6 years of age and older: chew 1 tablet until crushed. brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician. spit out: do not swallow the tablet. children under 6 years of age should be supervised when using this product.
Warnings:
Do not use it for anything other than brushing teeth, and be careful not to swallow it. if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.keep out of the reach of children. small tablets may be a chocking hazard for children under 3 years old. keep it away from the pets. when using this product, if irritation or sensitivity occurs, discontinue use.
Do Not Use:
Do not use it for anything other than brushing teeth, and be careful not to swallow it. if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.keep out of the reach of children. small tablets may be a chocking hazard for children under 3 years old. keep it away from the pets. when using this product, if irritation or sensitivity occurs, discontinue use.
When Using:
⪠adults and children 6 years of age and older: chew 1 tablet until crushed. ⪠brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician. ⪠spit out: do not swallow the tablet. ⪠children under 6 years of age should be supervised when using this product.
Dosage and Administration:
Gently chew 1 tablet until it crushed. brush teeth thoroughly,
Package Label Principal Display Panel:
Drug facts drug facts