Opalescence Sensitivity Relief Whitening
Potassium Nitrate And Sodium Fluoride
Ultradent Products, Inc.
Human Otc Drug
NDC 51206-308Opalescence Sensitivity Relief Whitening also known as Potassium Nitrate And Sodium Fluoride is a human otc drug labeled by 'Ultradent Products, Inc.'. National Drug Code (NDC) number for Opalescence Sensitivity Relief Whitening is 51206-308. This drug is available in dosage form of Gel, Dentifrice. The names of the active, medicinal ingredients in Opalescence Sensitivity Relief Whitening drug includes Potassium Nitrate - 50 mg/g Sodium Fluoride - 1.1 mg/g . The currest status of Opalescence Sensitivity Relief Whitening drug is Active.
Drug Information:
| Drug NDC: | 51206-308 |
| 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: | Opalescence Sensitivity Relief Whitening |
| 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: | Potassium Nitrate And Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ultradent Products, Inc. |
| 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: | POTASSIUM NITRATE - 50 mg/g
SODIUM FLUORIDE - 1.1 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| 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 NOT 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: | 30 Nov, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | part356 |
| 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: | Ultradent Products, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086243
|
| 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: | RU45X2JN0Z
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 |
|---|
| 51206-308-01 | 1 TUBE in 1 CARTON (51206-308-01) / 28.35 g in 1 TUBE | 30 Nov, 2015 | N/A | No |
| 51206-308-02 | 1 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE | 30 Nov, 2015 | N/A | No |
| 51206-308-03 | 3 CARTON in 1 PACKAGE, COMBINATION (51206-308-03) / 1 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE | 30 Nov, 2015 | N/A | No |
| 51206-308-04 | 12 CARTON in 1 PACKAGE, COMBINATION (51206-308-04) / 1 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE | 30 Nov, 2015 | N/A | No |
| 51206-308-05 | 24 CARTON in 1 PACKAGE, COMBINATION (51206-308-05) / 1 TUBE in 1 CARTON (51206-308-01) / 28.35 g in 1 TUBE | 30 Nov, 2015 | N/A | No |
| 51206-308-06 | 6 CARTON in 1 PACKAGE, COMBINATION (51206-308-06) / 1 TUBE in 1 CARTON (51206-308-02) / 133 g in 1 TUBE | 30 Nov, 2015 | 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:
Active ingredients purpose potassium nitrate 5% w/w antihypersensitivity sodium fluoride 0.25% w/w anticavity
Product Elements:
Opalescence sensitivity relief whitening potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion glycerin xanthan gum water sorbitol sodium hydroxide xylitol sodium benzoate sucralose silicon dioxide methyl salicylate sodium lauryl sulfate cool mint
Indications and Usage:
Uses helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.
Warnings:
Warnings sensitive teeth may indicate a serious problem that may need prompt care by a dentist. see your dentist if the problem persists or worsens. do not use this product longer than 4 weeks unless recommended by a dentist or doctor. keep out of reach of children under 6 years of age. if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or doctor.
Package Label Principal Display Panel:
Principal display panel - 133 g tube carton opalescence ⢠whitening toothpaste cool mint sensitivity relief net wt. 4.7 oz ⢠133 g ⢠100 ml fluoride toothpaste for sensitive teeth principal display panel - 133 g tube carton
Further Questions:
Questions or comments call toll-free 1.800.552.5512