Releev Cold Sore Treatment
Benzalkonium Chloride
Merix Pharmaceutical Corp.
Human Otc Drug
NDC 63287-419Releev Cold Sore Treatment also known as Benzalkonium Chloride is a human otc drug labeled by 'Merix Pharmaceutical Corp.'. National Drug Code (NDC) number for Releev Cold Sore Treatment is 63287-419. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Releev Cold Sore Treatment drug includes Benzalkonium Chloride - 1.3 mg/mL . The currest status of Releev Cold Sore Treatment drug is Active.
Drug Information:
| Drug NDC: | 63287-419 |
| 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: | Releev Cold Sore Treatment |
| 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Merix Pharmaceutical Corp. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | BENZALKONIUM CHLORIDE - 1.3 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | 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 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: | 01 Jun, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | part333A |
| 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: | Merix Pharmaceutical Corp.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049254
1095485
|
| 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: | 0643689419062
|
| UPC stands for Universal Product Code. |
| UNII: | F5UM2KM3W7
|
| 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 |
|---|
| 63287-419-01 | 1 POUCH in 1 BLISTER PACK (63287-419-01) / 1 BOTTLE, DROPPER in 1 POUCH / 1 mL in 1 BOTTLE, DROPPER | 01 Jun, 2006 | N/A | No |
| 63287-419-06 | 1 BOTTLE, DROPPER in 1 BLISTER PACK (63287-419-06) / 6 mL in 1 BOTTLE, DROPPER | 01 Jun, 2006 | N/A | No |
| 63287-419-33 | 1 BOTTLE, DROPPER in 1 BLISTER PACK (63287-419-33) / 3 mL in 1 BOTTLE, DROPPER | 21 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. |
Purpose:
Purpose cold sore/ fever blister treatment
Product Elements:
Releev cold sore treatment benzalkonium chloride hypromellose 2910 (4000 mpa.s) echinacea purpurea flowering top methylparaben potassium sorbate water propylparaben benzalkonium chloride benzalkonium
Indications and Usage:
Uses: treats cold sores/ fever blisters. for the pain, tingling, itching, & burning associated with cold sores. may be used as an antiseptic to help cleanse or dry cold sores & fever blisters. may be used inside the mouth on sores.
Warnings:
Warnings: for external use only do not use: ⢠if you have ever had an allergic reaction to this product or any of its ingredients. ⢠do not swallow. ⢠do not use for yeast infections (may be used in conjunction with yeast medication). ⢠avoid contact with eyes. ⢠if condition worsens or does not improve, contact a health care professional. when using this product ⢠use only as directed ⢠brief tingling may occur.
Dosage and Administration:
Directions: shake well (adults and children 12 years of age or older) apply to clean, dry, affected area 3-4 times per day by dabbing and pressing solution into the area well. allow to dry. best when used at first sign of outbreak. do not use cotton applicator.
Package Label Principal Display Panel:
Packaging releev