Acyclovir / Hydrocortisone
Acyclovir / Hydrocortisone is an antiviral plus anti-inflammatory steroid combination, used as a skin product (Xerese) for the early treatment of recurrent cold sores.
🧬 Where this information comes from
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Xerese pairs acyclovir, an antiviral that blocks the cold sore virus from copying its DNA, with hydrocortisone, a mild steroid that calms inflammation; on the market since about 2009 from a single maker, it is a less common choice for recurrent cold sores than antiviral medicines taken by mouth. Most people tolerate it well, with mild irritation where it is applied the usual complaint. Use it only on the lips and skin around the mouth, and if a sore has not healed within 2 weeks, see your provider, since a bacterial or fungal infection can look like a cold sore.
Clinical pearls
- Start at the first tingle, since it is meant to keep a cold sore from turning into an open ulcer.
- Cover the whole sore and its outer edge, then try not to rub the area afterward.
- Stop using it if the skin turns redder or more irritated, which can signal an allergic-type reaction to the cream.
- It is approved for children 6 and older, and it has not been studied in younger children.
Patient Information Guide A plain-language walkthrough of Acyclovir / Hydrocortisone, written from its FDA label.
What Acyclovir / Hydrocortisone Is Used For
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Acyclovir / Hydrocortisone is used for one condition in the supported product:
- Xerese (topical) is used for the early treatment of recurrent cold sores (herpes labialis), to reduce the chance of ulcerative cold sores and shorten healing time, in adults and children 6 years and older.
How Acyclovir / Hydrocortisone Works
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Acyclovir is an antiviral that is active against herpes simplex viruses (types 1 and 2). Herpes virus enzymes activate it, and it then blocks the virus from copying its DNA.
Hydrocortisone is a corticosteroid that reduces inflammation. Over time, herpes viruses can develop resistance to acyclovir. This is worth considering if a treatment does not work.
Acyclovir / Hydrocortisone Dosage
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Xerese is applied to the skin 5 times a day for 5 days. Start it as early as possible, ideally when you first feel symptoms or a sore appears.
- Cover the whole sore, including its outer edge.
- Avoid unnecessary rubbing, which can aggravate or spread the infection.
- Children 6 and older use the same schedule as adults.
Dosing details from the FDA-approved label
From the Acyclovir / Hydrocortisone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recurrent herpes labialis (cold sores) in adults and adolescents; initiate therapy as early as possible after first signs and symptoms (during the prodrome or when lesions appear)
- Topically apply XERESE 5 times per day for 5 days
- For each dose, topically apply a quantity sufficient to cover the affected area, including the outer margin
- Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.
- Children 6 years of age and older
- The dosage is the same as in adults: topically apply XERESE 5 times per day for 5 days
- Same as adult dosage for children 6 years of age and older.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). For each dose, topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. For children 6 years of age and older, the dosage is the same as in adults. Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). (2)
Read the full Dosage and Administration section on DailyMed →
Acyclovir / Hydrocortisone Side Effects
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Xerese can cause skin irritation and contact sensitization (an allergic-type skin reaction).
See your doctor if a sore has not healed within 2 weeks or if your skin reacts badly.
Acyclovir / Hydrocortisone Warnings and Precautions
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- Use only on cold sores of the lips and around the mouth.
- Do not use in the eyes, inside the mouth or nose, or on the genitals.
- Other sores, such as bacterial or fungal infections, can look like cold sores.
- See a provider if a sore has not healed within 2 weeks.
- It can cause irritation and contact sensitization.
Acyclovir / Hydrocortisone Interactions
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No drug interaction studies have been done with Xerese. Tell your pharmacist about everything you use so they can check for you.
Interactions listed in the FDA-approved label
From the Acyclovir / Hydrocortisone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
No drug interaction studies have been performed with XERESE. No drug interaction studies have been performed with XERESE.
Read the label’s full interactions text
7 DRUG INTERACTIONS No drug interaction studies have been performed with XERESE. No drug interaction studies have been performed with XERESE. (7)
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before Taking Acyclovir / Hydrocortisone
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- There are no listed contraindications for Xerese.
- Safety and effectiveness in children under 6 are not established.
- Pregnancy: no data on Xerese itself. Studies of topical acyclovir and low or medium potency topical steroids have not linked them to birth defects or miscarriage, though studies have limits.
- Breastfeeding: no data, but exposure after topical use is expected to be minimal. Weigh the benefits of breastfeeding and your need for treatment.
- Older adults: too few people over 65 were studied to be certain.
- Weakened immune system: benefit has not been adequately assessed, so talk with a doctor.
Acyclovir / Hydrocortisone Overdose
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Overdose from applying Xerese to the skin is unlikely because very little gets into the body.
How Your Body Processes Acyclovir / Hydrocortisone
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Blood levels of acyclovir and hydrocortisone were not measured after Xerese was applied to cold sores. Topical steroids can be absorbed through the skin, more so when the skin barrier is damaged or inflamed. Once absorbed, steroids are broken down mainly in the liver and cleared by the kidneys.
How to Store Acyclovir / Hydrocortisone
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Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Acyclovir / Hydrocortisone: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Acyclovir / Hydrocortisone — the kind of thing our pharmacy team would talk through with you at the counter.
What is Xerese used for?
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How do I use it?
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Can I use it in my mouth, nose or eyes?
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When should I call my doctor?
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Is it safe in pregnancy or while breastfeeding?
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Can my child use it?
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Is Acyclovir / Hydrocortisone available over the counter?
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When was Acyclovir / Hydrocortisone first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Acyclovir / Hydrocortisone on HelloPharmacist
Acyclovir / Hydrocortisone Forms and Strengths (How It Comes)
Acyclovir / Hydrocortisone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Acyclovir / Hydrocortisone inactive ingredients by manufacturer.
Topical cream, ointment or gel
How this form is used
- Xerese is used for the early treatment of recurrent cold sores (herpes labialis).
- Xerese is for adults and children 6 years and older.
- Xerese is applied 5 times a day for 5 days.
- Start Xerese as early as possible, at the first signs or when a lesion appears.
- Apply enough Xerese to cover the sore and its outer edge.
- Avoid unnecessary rubbing of the area.
Acyclovir / Hydrocortisone on the U.S. Market: Products, Makers and Brands
How Acyclovir / Hydrocortisone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Acyclovir / Hydrocortisone product record with the FDA, mostly as topical cream, ointment or gel; the earliest marketing or approval year on record is 2009. Brand names on the directory include Xerese; the rest are generics.
How Widely Acyclovir / Hydrocortisone Is Used (Medicaid Data)
A general measure of how commonly Acyclovir / Hydrocortisone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Acyclovir / Hydrocortisone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Acyclovir / Hydrocortisone prescribed? Of the 1,603 medications we measure, Acyclovir / Hydrocortisone ranks #1,599 by Medicaid prescriptions — more than 0% of them.
Utilization by Acyclovir / Hydrocortisone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
acyclovir 50 MG/ML / hydrocortisone 10 MG/ML Topical Cream
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998422
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Acyclovir / Hydrocortisone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Acyclovir / Hydrocortisone NDCs with Medicaid activity.
Compare Acyclovir / Hydrocortisone Products
A representative set of FDA-listed product records for Acyclovir / Hydrocortisone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| ACYCLOVIR 50 mg/g; HYDROCORTISONE 10 mg/g | Topical | Bausch Health US LLC | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Acyclovir / Hydrocortisone NDCs →
Acyclovir / Hydrocortisone Side Effects Reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Acyclovir / Hydrocortisone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Acyclovir / Hydrocortisone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Acyclovir / Hydrocortisone FDA Approval History
How Acyclovir / Hydrocortisone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Acyclovir / Hydrocortisone Recall History
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Acyclovir / Hydrocortisone recalls since July 2021.
✅No Acyclovir / Hydrocortisone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1007804 1 dose form · 1 strength
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Dose form (SCDF) Topical Cream RxCUI 998421In current FDA listingsClinical drug / strength (SCD) acyclovir 50 MG/ML / hydrocortisone 10 MG/MLRxCUI 998422
Look up RxCUI 1007804 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Acyclovir / Hydrocortisone Supply and Shortage Status
Whether Acyclovir / Hydrocortisone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Acyclovir / Hydrocortisone Brand Names
Acyclovir / Hydrocortisone is sold under one brand name in the FDA directory — Xerese. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Acyclovir / Hydrocortisone: Manufacturers and Labelers
One company lists Acyclovir / Hydrocortisone products with the FDA. By number of product records, the largest are Bausch Health US LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Acyclovir / Hydrocortisone Drug Class (RxNorm)
Acyclovir / Hydrocortisone belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for This Acyclovir / Hydrocortisone Page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bausch Health US LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →