Docosanol


Dolgencorp, Inc. (dollar General & Rexall)
Human Otc Drug
NDC 55910-722
Docosanol is a human otc drug labeled by 'Dolgencorp, Inc. (dollar General & Rexall)'. National Drug Code (NDC) number for Docosanol is 55910-722. 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: 55910-722
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: Dolgencorp, Inc. (dollar General & Rexall)
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: 30 Jun, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 Jun, 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: ANDA208754
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:Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
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:0359726922081
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
55910-722-071 TUBE in 1 PACKAGE (55910-722-07) / 2 g in 1 TUBE30 Jun, 2020N/ANo
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:

Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

Warnings:

Warnings allergy alert: this product may cause a severe allergic reaction. symptoms may cause: hives facial swelling wheezing/difficulty breathing shock rash if an allergic reaction occurs, stop use and seek medical help right away

Do Not Use:

Warnings allergy alert: this product may cause a severe allergic reaction. symptoms may cause: hives facial swelling wheezing/difficulty breathing shock rash if an allergic reaction occurs, stop use and seek medical help right away

When Using:

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.

Dosage and Administration:

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

Stop Use:

Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days

Package Label Principal Display Panel:

Principal display panel compare to active ingredient of abreva®† docosanol cream 10% cold sore/fever blister treatment non-prescription medicine to shorten healing time* cold sore treatment for topical use only docosanol cream, 10% thank you for purchasing docosanol cream. we hope that since docosanol cream shortens the healing time of cold sores, it helps you look and feel better faster. please follow insert directions for proper use and refer to the information below. you are not alone an estimated one-in-five americans is affected by cold sores each year. most people who experience them get two to three cold sore outbreaks each year. just before and during an outbreak, the cold sore infection can be easily passed on to others. it is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one. getting to the root of the problem a blister, or cluster of blisters around your mouth, is caused by the cold sore virus. after the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation. the sooner, the better a typical cold sore outbreak can last as long as seven to ten days. the sooner you begin using docosanol cream, the more effective the medicine will be. so for best results, use docosanol cream at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch. docosanol cream is different from other over-the-counter cold sore products. only docosanol cream contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of symptoms including tingling, pain, itching and burning. frequently asked questions: how is docosanol cream different from the over-the-counter cold sore remedies i have already been using? docosanol cream is a non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. the sooner you start using docosanol cream, the sooner you can begin healing your cold sore. who can use docosanol cream? adults and children 12 years and over can use docosanol cream. how often can i apply docosanol cream? docosanol cream should be used five times a day until the cold sore is healed. apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results. can i apply cosmetics on top of docosanol cream? yes, cosmetics such as lipstick may be applied over docosanol cream. however, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. for best results, remove any cosmetics prior to applying docosanol cream *non-prescription of cold sore medicine to shorten healing time and duration of symptoms †this product is not manufactured or distributed by gsk consumer healthcare, distributor of abreva®. retain this insert for full product uses directions and warnings. distributed by old east main co. 100 mission ridge goodlettsville, tn 37072

Package label dollar general health docosanol cream 10% docosanol 10%

Further Questions:

Questions or comments? call 1-888-309-9030


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.