Dentemp Canker Cover
Canker Cover
Doc Brands
Human Otc Drug
NDC 73653-212Dentemp Canker Cover also known as Canker Cover is a human otc drug labeled by 'Doc Brands'. National Drug Code (NDC) number for Dentemp Canker Cover is 73653-212. This drug is available in dosage form of Tablet, Extended Release. The names of the active, medicinal ingredients in Dentemp Canker Cover drug includes Menthol - 2.5 mg/1 . The currest status of Dentemp Canker Cover drug is Active.
Drug Information:
| Drug NDC: | 73653-212 |
| 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: | Dentemp Canker Cover |
| 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: | Canker Cover |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Doc Brands |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Extended Release |
| 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: | MENTHOL - 2.5 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
TOPICAL
|
| 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: | 02 Feb, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 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. |
| Application Number: | M022 |
| 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, 2024 |
| 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: | DOC Brands
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2628246
|
| 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: | 0372494102127
|
| UPC stands for Universal Product Code. |
| UNII: | L7T10EIP3A
|
| 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 |
|---|
| 73653-212-04 | 4 BLISTER PACK in 1 CARTON (73653-212-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (73653-212-01) | 02 Feb, 2023 | 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:
Purpose ora pain reliever
Product Elements:
Dentemp canker cover canker cover magnesium chloride silicon dioxide annatto carbomer homopolymer type a citrus limon fruit oil hydroxypropyl cellulose, unspecified povidone k30 povidone k90 menthol menthol xylitol one side pink, one side white
Indications and Usage:
Indications for the temporary relief of pain associated with canker sores
Warnings:
Warnings do not use this product for more than 7 days unless directed by a dentist or doctor. stop use and ask a dentist or doctor if ⢠sore mouth symptoms do not improve in 7 days ⢠irritation, pain or redness worsens ⢠swelling, rash or fever develops. do not exceed recommended dosage.
Dosage and Administration:
Directions ⢠adults and children 5 years of age and older, apply up to 3 tablets a day, as needed. place the tablet on a clean, dry finger with the white side up. place the white side on the sore and hold in place for 10 seconds. if sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the tablet along the score and use half. some discomfort may occur during the first few minutes, but will quickly subside, followed by hours of soothing relief. within 30 minutes, the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before dissolving. do not remove the tablet before it dissolves. in case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while washing with warm water. do not use any instrument to remove the tablet. ⢠children under 5 years, ask a doctor.
Package Label Principal Display Panel:
Canker cover 4ct packaging
Further Questions:
Questions or comments? 833-362-2763 or consumeraffairs@doc-brands.com