Prescription medicine
Acyclovir and hydrocortisone Brand names: Xerese
Acyclovir and hydrocortisone (Xerese) is a prescription medicine with an FDA approval on record since 2009. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the acyclovir and hydrocortisone FDA label on DailyMed (effective August 3, 2020, Bausch Health US LLC); the NDA 22436 record on Drugs@FDA; every acyclovir and hydrocortisone label on DailyMed.
Highlights of the record
FDA label of August 3, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXERESE, 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).
Forms and strengths
- 50 mg/g / 10 mg/g
Cream.
On the market
- Earliest approval on file
- July 31, 2009 Xerese, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 40 through July 30, 2026
What is acyclovir and hydrocortisone used for?
From the label: indications and usageXERESE, 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). […]
Conditions named in the indications of acyclovir and hydrocortisone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Corticosteroid, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor and Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor.
Source: FDA drug label (Xerese), Bausch Health US LLC, effective August 3, 2020 (SPL set 3b6ac164-0f1e-4f36-94a1-1fdb07d710f5), via openFDA; the full label on DailyMed
Is there a generic for acyclovir and hydrocortisone (Xerese)?
No generic acyclovir and hydrocortisone is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for acyclovir and hydrocortisone?
The FDA Adverse Event Reporting System holds 40 reports that list acyclovir and hydrocortisone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 5 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acyclovir and hydrocortisone?
3 other medicines are given the same way (topical) and in the same FDA class as acyclovir and hydrocortisone or labeled mainly for the same use (herpes and shingles), the same class first. Herpes and shingles lists all 15 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Penciclovir | Herpes and shingles | 3 labelers | $52.15 per gram 1% cream | No current entry |
| Dexamethasone | Herpes and shingles | none listed | n/a | In shortage |
| Allantoin | Herpes and shingles | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as acyclovir and hydrocortisone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to acyclovir and hydrocortisone
- 3 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Acyclovir and hydrocortisone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other