Docosanol
Aleor Dermaceuticals Limited
Human Otc Drug
NDC 71589-019Docosanol is a human otc drug labeled by 'Aleor Dermaceuticals Limited'. National Drug Code (NDC) number for Docosanol is 71589-019. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Docosanol drug includes Docosanol - 100 mg/g . The currest status of Docosanol drug is Active.
Drug Information:
| Drug NDC: | 71589-019 |
| 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: | Docosanol |
| 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: | Docosanol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aleor Dermaceuticals Limited |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | DOCOSANOL - 100 mg/g
|
| 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: | ANDA |
| 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: | 03 May, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | ANDA215839 |
| 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: | Aleor Dermaceuticals Limited
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797534
|
| 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: | 0371589019036
0371589019012
|
| UPC stands for Universal Product Code. |
| UNII: | 9G1OE216XY
|
| 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 |
|---|
| 71589-019-01 | 1 TUBE in 1 PACKAGE (71589-019-01) / 2 g in 1 TUBE | 03 May, 2022 | N/A | No |
| 71589-019-03 | 1 BOTTLE, PUMP in 1 PACKAGE (71589-019-03) / 2 g in 1 BOTTLE, PUMP | 03 May, 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:
Purpose cold sore/fever blister treatment
Product Elements:
Docosanol docosanol docosanol docosanol benzyl alcohol light mineral oil propylene glycol water sucrose distearate sucrose stearate
Indications and Usage:
Directions adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle). early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor
Warnings:
Warnings allergy alert this product may cause a severe allergic reaction. symptoms may include: hives facial swelling wheezing/difficulty breathing shock rash if an allergic reaction occurs, stop use and seek medical help right away. for external use only do not use if you are allergic to any ingredient in this product when using this product apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. this may spread the infection. stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days
Dosage and Administration:
Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching
Package Label Principal Display Panel:
Principal display panel tube pack ndc 71589-019-01 docosanol cream, 10% compare to the active ingredient in abreva®** cold sore/fever blister treatment non-prescription medicine to shorten healing time* cold sore treatment for topical use only net wt 2g (0.07 oz) **this product is not manufactured or distributed by gsk consumer healthcare, distributor of abreva®. *contains the only non-prescription cold sore medicine approved by the fda to shorten healing time and duration of symptoms. retain this insert for full product uses, directions and warnings manufactured for: aleor dermaceuticals ltd., karakhadi, vadodara 391450, india. pump pack ndc 71589-019-03 docosanol cream, 10% compare to the active ingredient in abreva®** cold sore/fever blister treatment non-prescription medicine to shorten healing time* cold sore treatment for topical use only net wt 2g (0.07 oz) **this product is not manufactured or distributed by gsk consumer healthcare, distributor of abreva®. *contains the only non-prescription cold sore medicine approved by the fda to shorten healing time and duration of symptoms. retain this insert for full product uses, directions and warnings manufactured for: aleor dermaceuticals ltd., karakhadi, vadodara 391450, india. tube pack pump pack