Xerese Cream
NDC 0187-5104

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0187-5104?
  4. Xerese Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Xerese (acyclovir and hydrocortisone) is a NDA-approved product labeled by Bausch Health Us Llc. This medication contains 2 ingredients: acyclovir and hydrocortisone. It is supplied as a cream for topical administration. This product entry covers the primary NDC 0187-5104 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Bausch Health Us Llc
Labeler Code:
0187
Product Label ID:
3b6ac164-0f1e-4f36-94a1-1fdb07d710f5
FDA Application Number: [6]
NDA022436
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-31-2009
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0187-5104?

The NDC code 0187-5104 is assigned by the FDA to the product Xerese. It is commonly known by its generic name, acyclovir and hydrocortisone. This pharmaceutical product is labeled by Bausch Health Us Llc and is currently categorized as listed product. The medication is a cream administered via topical route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0187-5104-01, 0187-5104-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".