NDC 0187-5104 Xerese

Acyclovir And Hydrocortisone Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0187-5104
Proprietary Name:
Xerese
Non-Proprietary Name: [1]
Acyclovir And Hydrocortisone
Substance Name: [2]
Acyclovir; Hydrocortisone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Bausch Health Us Llc
    Labeler Code:
    0187
    FDA Application Number: [6]
    NDA022436
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-31-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0187-5104-01

    Package Description: 1 TUBE in 1 CARTON / 5 g in 1 TUBE

    Price per Unit: $199.57516 per GM

    Product Details

    What is NDC 0187-5104?

    The NDC code 0187-5104 is assigned by the FDA to the product Xerese which is a human prescription drug product labeled by Bausch Health Us Llc. The generic name of Xerese is acyclovir and hydrocortisone. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 0187-5104-01 1 tube in 1 carton / 5 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Xerese?

    This medication contains 2 ingredients: acyclovir and hydrocortisone. It is used to treat cold sores/fever blisters caused by a virus (herpes simplex). Acyclovir is an antiviral medication that works by stopping the growth of the virus. Hydrocortisone is a corticosteroid that helps relieve itching, pain, and burning symptoms. This medication can speed up healing of cold sores, but it does not cure herpes or prevent passing the infection to someone else. It also does not prevent cold sores from returning.

    What are Xerese Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ACYCLOVIR 50 mg/g - A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.
    • HYDROCORTISONE 10 mg/g - The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

    Which are Xerese UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Xerese Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Xerese?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 998422 - acyclovir 5 % / hydrocortisone 1 % Topical Cream
    • RxCUI: 998422 - acyclovir 50 MG/ML / hydrocortisone 10 MG/ML Topical Cream
    • RxCUI: 998422 - acycycloguanosine 50 MG/ML / Hydrocortisone 10 MG/ML Topical Cream
    • RxCUI: 998426 - Xerese (acyclovir 5 % / hydrocortisone 1 % ) Topical Cream
    • RxCUI: 998426 - acyclovir 50 MG/ML / hydrocortisone 10 MG/ML Topical Cream [Xerese]

    * Please review the disclaimer below.

    Patient Education

    Acyclovir Topical


    Acyclovir cream is used to treat cold sores (fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. Acyclovir ointment is used to treat first outbreaks of genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time) and to treat certain types of sores caused by the herpes simplex virus in people with weak immune systems. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body. Acyclovir does not cure cold sores or genital herpes, does not prevent outbreaks of these conditions, and does not stop the spread of these conditions to other people.
    [Learn More]


    Hydrocortisone Topical


    Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - 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.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".