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Prescription medicine

Acyclovir and hydrocortisone

Brand names: Xerese

Active ingredients: acyclovir · hydrocortisone

Drug class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Corticosteroid

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2009First FDA approval on file

Quick answers

What is Acyclovir and hydrocortisone used for?
The FDA-approved label (Xerese, Bausch Health US LLC, August 3, 2020) says: “XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Acyclovir and hydrocortisone have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Acyclovir and hydrocortisone?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Acyclovir and hydrocortisone been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Acyclovir and hydrocortisone?
1 company lists prescription products of Acyclovir and hydrocortisone in the FDA NDC Directory, including Bausch Health US, LLC.

What Acyclovir and hydrocortisone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). …

— FDA label: Xerese, Bausch Health US LLC, effective August 3, 2020. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsCream
RouteTopical
Prescription products1 in the FDA NDC Directory
Brand namesXerese

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA022436
XERESE		 BauschJuly 31, 2009 5, latest December 11, 2019
2019: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)998422, 998426
SPL set ID of the quoted label3b6ac164-0f1e-4f36-94a1-1fdb07d710f5
FDA labels (SPL)1
FDA applicationsNDA022436
Active ingredients (FDA)ACYCLOVIR / HYDROCORTISONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Xerese, Bausch Health US LLC, effective August 3, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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