Acyclovir / Hydrocortisone
Acyclovir/hydrocortisone is a combination antiviral and anti-inflammatory cream used to treat recurrent herpes labialis (cold sores) on the lips and around the mouth.
🧬 Where this information comes from Click to expand
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 →
📖 Acyclovir / Hydrocortisone: Patient Information Guide
A plain-language walkthrough of Acyclovir / Hydrocortisone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Acyclovir/hydrocortisone is a topical combination medication supported for the following use:
- Xerese cream is indicated for the early treatment of recurrent herpes labialis (cold sores) on the lips and skin around the mouth in adults and children 6 years of age and older.
- Xerese is used to reduce the likelihood that a cold sore will become an ulcerative (open) sore.
- Xerese is used to shorten the time it takes a cold sore lesion to heal.
⚙️How it works▾
Acyclovir is an antiviral drug that works by mimicking the building blocks of viral DNA. Herpes simplex virus (HSV-1 and HSV-2) activates acyclovir inside infected cells by converting it into an active form that blocks the viral enzyme needed to copy the virus's genetic material. This stops the virus from replicating and spreading. Hydrocortisone is a mild corticosteroid that reduces the inflammation — swelling, redness, and irritation — associated with a cold sore outbreak.
One thing worth knowing: like other antiviral drugs, acyclovir can lose effectiveness if the virus develops resistance — a change in the viral enzymes that makes the drug less able to block replication. This is more of a concern in people with weakened immune systems or those who experience repeated treatment failures.
💊How it's taken▾
Xerese cream is applied to the affected area five times a day for five days. Starting treatment early — at the very first tingle, itch, or redness — gives the best results. Apply a thin layer that covers the sore and its surrounding edge.
- Use it five times per day for exactly five days.
- Apply as soon as the first symptoms appear — early use matters.
- Avoid rubbing the area more than needed; it can aggravate or spread the infection.
- This is for skin use only — not for internal use. Follow your prescriber and the label for all details.
🤒Side effects — in detail▾
The most commonly reported side effects with Xerese are local skin reactions at the application site:
- Skin irritation where the cream is applied
- Contact sensitization — an allergic-type skin reaction at the site
- Skin dryness or flaking
If you notice a sore that isn't healing within two weeks, or if your skin reaction seems severe or is spreading, contact your doctor — this could point to a different type of infection or an allergic reaction that needs attention.
⚠️Warnings & precautions▾
- For external use only: Xerese should only be applied to the lips and surrounding skin. Never use it in or near the eye, inside the mouth or nose, or on the genitals.
- Not all lip sores are cold sores: Bacterial and fungal infections can look similar to herpes labialis. If the sore doesn't start to heal within 2 weeks, see a doctor.
- Skin irritation and allergic reactions: Xerese can cause irritation or contact sensitization at the site. If you notice worsening redness, swelling, or a rash, stop using it and contact your doctor.
- Immunocompromised patients: People with weakened immune systems (such as those with HIV) should talk to their doctor before using Xerese — the benefit in this group has not been adequately established.
- Corticosteroid absorption: Although absorption through the skin is expected to be low when used as directed, broken or inflamed skin can allow more hydrocortisone to enter the bloodstream.
🔀What it interacts with▾
No formal drug interaction studies have been conducted with Xerese. Talk to your pharmacist or doctor about all medications, supplements, and skin products you use alongside Xerese.
- Other topical products: Using other creams or ointments on the same area at the same time has not been studied — check with your doctor before combining treatments.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Children under 6: Safety and effectiveness of Xerese have not been established in children younger than 6 years of age.
- Pregnancy: Tell your doctor if you are pregnant. Published observational data on topical acyclovir and low-potency topical corticosteroids have not shown a clear association with birth defects or pregnancy complications, and systemic absorption from topical Xerese is expected to be minimal — but discuss any concerns with your doctor.
- Breastfeeding: There are no data on whether acyclovir or hydrocortisone pass into breast milk after topical application. Discuss use of Xerese with your doctor if you are breastfeeding.
- Weakened immune system: People who are immunocompromised should consult a doctor before using Xerese, as the benefit in this population has not been adequately proven.
- Older adults (65+): There were too few patients over 65 in clinical studies to draw firm conclusions, though available results were similar to those of younger patients.
- Skin conditions that mimic cold sores: If you are unsure whether your lesion is a cold sore, check with your doctor before using Xerese.
🚑If you take too much▾
An overdose from applying Xerese to the skin is unlikely, because the amount absorbed into the bloodstream through topical use is minimal. If you or someone else accidentally swallows Xerese, contact Poison Control or seek medical attention right away.
🔬Pharmacokinetics — how your body processes it▾
After applying Xerese to the skin, blood levels of acyclovir and hydrocortisone were not measured in studies, so the exact amount absorbed is not known. In general, topical corticosteroids like hydrocortisone can be absorbed through intact skin, and that absorption increases when the skin is broken or inflamed — both of which can occur with cold sores. Once absorbed, hydrocortisone is processed similarly to other corticosteroids: it is broken down mainly in the liver and cleared by the kidneys, with some elimination through bile as well. Overall systemic exposure from topical use on a small area is expected to be low.
📦How to store it▾
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 Acyclovir / Hydrocortisone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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 exactly does Xerese do for a cold sore? ▾
When is the best time to start using it? ▾
How do I apply it correctly? ▾
Can I use Xerese if I'm pregnant or breastfeeding? ▾
What side effects should I watch for — and when should I call my doctor? ▾
Is it safe to use if I have a weakened immune system? ▾
Is Acyclovir / Hydrocortisone available over the counter? ▾
When was Acyclovir / Hydrocortisone first available? ▾
💬 Answers drafted from Acyclovir / Hydrocortisone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Acyclovir / Hydrocortisone 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.
Topical cream, ointment or gel
How this form is used
- Xerese is used for the early treatment of recurrent herpes labialis (cold sores) on the lips and around the mouth in adults and children 6 years and older.
- Xerese reduces the likelihood that a cold sore will develop into an open ulcer.
- Xerese helps shorten the time it takes for a cold sore to heal.
- Xerese is applied to the skin five times a day for five days.
- Start Xerese as early as possible — at the first sign of tingling, redness, or a lesion.
- Apply enough Xerese to cover the sore and its outer margin; avoid unnecessary rubbing.
- Xerese is for external use on lips and surrounding skin only — do not use in the eye, inside the mouth or nose, or on the genitals.
📊 Acyclovir / Hydrocortisone across the U.S. market
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.
📈 How widely Acyclovir / Hydrocortisone is used
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 1,596 medications we measure, Acyclovir / Hydrocortisone ranks #1,592 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 →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Acyclovir / Hydrocortisone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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
-
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.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
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.
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch Health US LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.