Abreva
Docosanol
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0200Abreva also known as Docosanol is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Abreva is 0135-0200. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Abreva drug includes Docosanol - 100 mg/g . The currest status of Abreva drug is Active.
Drug Information:
| Drug NDC: | 0135-0200 |
| 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: | Abreva |
| 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: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| 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: | NDA |
| 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: | 19 Mar, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 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: | NDA020941 |
| 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797534
855205
|
| 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: | 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 |
|---|
| 0135-0200-01 | 2 g in 1 TUBE (0135-0200-01) | 19 Mar, 2010 | N/A | No |
| 0135-0200-03 | 2 g in 1 BOTTLE, PUMP (0135-0200-03) | 19 Mar, 2010 | N/A | No |
| 0135-0200-05 | 2 TUBE in 1 PACKAGE (0135-0200-05) / 2 g in 1 TUBE | 06 Jul, 2017 | 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:
Abreva 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 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 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 infection. stop use and ask a doctor if ⢠your cold sore gets worse or the cold sore is not healed within 10 days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
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 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 infection. stop use and ask a doctor if ⢠your cold sore gets worse or the cold sore is not healed within 10 days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product ⢠apply only to 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 infection.
Dosage and Administration:
Directions ⢠adults and children 12 years or over : ⢠wash hands before and after applying cream ⢠apply to affected area on 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 ndc 0135-0200-01 abreva docosanol 10% cream gsk cold sore/fever blister treatment cold sore treatment beauty unaltered net wt 2g (0.07 oz) 1000771 abreva 2g tube print card
Further Questions:
Questions or comments? call toll-free 1-877-709-3539