Xerese Acyclovir and Hydrocortisone 50 mg/g; 10 mg/g Cream
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Xerese works on two fronts. The acyclovir in it is an antiviral that stops the herpes virus from multiplying, which helps limit how bad the sore gets. The hydrocortisone is a mild...
- What exactly does Xerese do for a cold sore?
- As soon as possible — ideally the moment you feel that familiar tingling or itching, even before a visible sore appears. That early window is when antiviral treatment does the most...
- When is the best time to start using it?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $238.53 | $1,192.64 / 5 g |
| Medicare drug plans payPart D · Q2 2026 | $254.92 | $1,274.60 / 5 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Xerese 50 mg/g; 10 mg/gthis 00187-5104-01 | Bausch | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00187-5104-01 You're viewing this | 1 TUBE in 1 CARTON (0187-5104-01) / 5 g in 1 TUBE | 2009-07-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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). 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).
(1)
⏱️ Dosage and Administration ▾
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)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base. Cream: 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Only for topical use for recurrent herpes labialis on the lips and around the mouth. (5)
5.1General XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals. There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore.
Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks. XERESE has a potential for irritation and contact sensitization [see Adverse Reactions (6.1) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following most common adverse reactions (<1%) were local skin reactions: Drying or flaking of the skin; burning or tingling, erythema; pigmentation changes; application site reactions including signs and symptoms of inflammation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The safety data derived from XERESE clinical trials reflect exposure to XERESE in 1,056 subjects with recurrent herpes labialis treated 5 times daily for 5 days. The most common adverse reactions (<1%) were local skin reactions, and occurred in the area of the application site, including: - Drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.
Contact dermatitis following application has been observed when applied under occlusion in dermal safety trials. Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base. A trial enrolling 225 healthy adults was conducted to evaluate the contact sensitization potential of XERESE using repeat insult patch testing methodology.
Of 205 evaluable subjects, one confirmed case (0.5%) of sensitization to hydrocortisone and 2 additional cases (1.0%) of possible sensitization to the XERESE base were identified. Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base. Dermal tolerance was assessed in a 21-day cumulative irritation trial in 36 healthy subjects.
XERESE, its cream base and Zovirax ® (acyclovir) Cream 5% all showed a high and cumulative irritation potential under occlusive and semi-occlusive conditions. Photoallergic potential and phototoxicity were assessed in two trials in 50 and 30 healthy volunteers, respectively. No photoallergic or phototoxicity potential was identified for XERESE.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been performed with XERESE. No drug interaction studies have been performed with XERESE. (7)
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Immunocompromised Patients: Benefit has not been adequately assessed. (8.6)
8.1Pregnancy Risk Summary There are no available data on XERESE use in pregnant women. However, published observational studies over decades of use of topical acyclovir and low and medium potency topical corticosteroids during pregnancy have not established any association between use of these products and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Animal reproduction studies have not been conducted with XERESE.
Systemic exposure of acyclovir and hydrocortisone following topical administration of XERESE is expected to be minimal. Animal reproduction studies with systemic exposure of acyclovir and hydrocortisone have been conducted. Refer to acyclovir and hydrocortisone prescribing information for additional details.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Human Data While available studies cannot definitively establish the absence of risk, published data from multiple large observational studies have not established an association with the use of topical acyclovir or low and medium potency topical corticosteroids (including hydrocortisone) during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodological limitations including whether women who filled a prescription actually took the medication, non-randomized design, retrospective data collection, and the inability to control for confounders such as underlying maternal disease and use of concomitant medications.
8.2Lactation Risk Summary There are no data on the presence of acyclovir or hydrocortisone in human milk following topical administration. There are no data on the effects of acyclovir or hydrocortisone on the breastfed infant or on milk production. Systemic exposure following topical administration of either drug is expected to be minimal.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XERESE and any potential adverse effects on the breastfed child from XERESE or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.
8.5Geriatric Use In clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of XERESE in this group, although the available results were similar to lower age subjects.
8.6Immunocompromised Subjects Even though the safety of XERESE has been studied in immunocompromised subjects, data are insufficient to support use in this population. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection. Benefit has not been adequately assessed in immunocompromised patients.
A randomized, double-blind trial was conducted in 107 immunocompromised subjects with stable HIV infection and recurrent herpes labialis. Subjects had on average 3.7 episodes of herpes labialis in the previous 12 months. The median age was 30 years (range 19 to 64 years), 46% were female, and all Caucasian.
Median CD4+ T-cell count at screening was 344/mm 3 (range 100-500/mm 3 ). Subjects were treated with XERESE or 5% acyclovir in XERESE vehicle. The primary objective was to exclude a doubling of the healing time in either treatment arm.
The mean healing time for cold sores was similar between the two treatment groups: 6.6 days for XERESE and 6.9 days for 5% acyclovir in XERESE vehicle.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on XERESE use in pregnant women. However, published observational studies over decades of use of topical acyclovir and low and medium potency topical corticosteroids during pregnancy have not established any association between use of these products and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Animal reproduction studies have not been conducted with XERESE.
Systemic exposure of acyclovir and hydrocortisone following topical administration of XERESE is expected to be minimal. Animal reproduction studies with systemic exposure of acyclovir and hydrocortisone have been conducted. Refer to acyclovir and hydrocortisone prescribing information for additional details.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Human Data While available studies cannot definitively establish the absence of risk, published data from multiple large observational studies have not established an association with the use of topical acyclovir or low and medium potency topical corticosteroids (including hydrocortisone) during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodological limitations including whether women who filled a prescription actually took the medication, non-randomized design, retrospective data collection, and the inability to control for confounders such as underlying maternal disease and use of concomitant medications.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of XERESE in this group, although the available results were similar to lower age subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage by topical application of XERESE is unlikely because of minimal systemic exposure [see Clinical Pharmacology (12.3) ].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Acyclovir is an antiviral drug active against α-herpesviruses and hydrocortisone is an anti-inflammatory drug [see Microbiology (12.4) ].
12.3Pharmacokinetics The plasma concentrations of acyclovir and hydrocortisone were not measured following topical administration of XERESE on cold sores. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin and can have systemic side effects depending on both the potency of the corticosteroid and the surface area of application.
Inflammation and/or other disease processes in the skin that disrupt the skin barrier can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
12.4Microbiology Mechanism of Action Acyclovir is a synthetic purine deoxynucleoside analogue with inhibitory activity against herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) DNA polymerases. It inhibits HSV-1 and HSV-2 replication in cell culture and in vivo. The inhibitory activity of acyclovir is selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV.
This viral enzyme converts acyclovir into acyclovir monophosphate, a deoxynucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In biochemical assays, acyclovir triphosphate inhibits replication of α-herpes viral DNA.
This inhibition is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.
Antiviral Activity The quantitative relationship between the susceptibility of herpes viruses to antivirals in cell culture and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (EC 50 value), vary greatly depending upon a number of factors. Using plaque-reduction assays on Vero cells, the EC 50 value of acyclovir against herpes virus isolates ranged from 0.09 to 60 µM (0.02 to 13.5 µg/mL) for HSV-1 and from 0.04 to 44 µM (0.01 to 9.9 µg/mL) for HSV-2.
Resistance In Cell Culture Acyclovir-resistant HSV-1 and HSV-2 strains were isolated in cell culture. Acyclovir-resistant HSV resulted from mutations in the viral thymidine kinase (TK; pUL23) and DNA polymerase (POL; pUL30) genes. Frameshifts were commonly isolated and result in premature truncation of the HSV TK product with consequent decreased susceptibility to acyclovir.
Mutations in the viral TK gene may lead to complete loss of TK activity (TK negative), reduced levels of TK activity (TK partial), or alteration in the ability of viral TK to phosphorylate the drug without an equivalent loss in the ability to phosphorylate thymidine (TK altered). In cell culture the following resistance-associated substitutions in TK of HSV-1 and HSV-2 were observed (Table 1). Table 1: Summary of Acyclovir (ACV) Resistance-associated Amino Acid Substitutions in Cell Culture HSV-1 TK P5A, H7Q, L50V, G56…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Acyclovir is an antiviral drug active against α-herpesviruses and hydrocortisone is an anti-inflammatory drug [see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING XERESE is supplied in a plastic-laminated aluminum tube containing 5 g of XERESE. Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base. NDC 0187-5104-01 5 g tubes 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.
📋 Description ▾
11 DESCRIPTION XERESE contains acyclovir, a synthetic nucleoside analogue active against herpes viruses, and hydrocortisone, an anti-inflammatory corticosteroid, combined in a cream for topical administration. Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) of acyclovir, 10 mg (equivalent to 1%, w/w) of hydrocortisone and the following inactive ingredients: cetostearyl alcohol, citric acid monohydrate, isopropyl myristate, mineral oil, Poloxamer 188, propylene glycol, purified water, USP, sodium hydroxide, sodium lauryl sulfate, and white petrolatum.
Sodium hydroxide or hydrochloric acid may have been added to adjust the pH to approximately pH 5. Acyclovir, 2-Amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one, is a synthetic nucleoside analogue active against herpes viruses. The maximum solubility of acyclovir in water at 37°C is 2.5 mg/mL.
The pKa’s of acyclovir are 2.27 and 9.25. Its empirical formula is C 8 H 11 N 5 O 3 . The structural formula is provided in Figure 1: Figure 1: Structural Formula of Acyclovir Hydrocortisone, pregn-4-ene-3,20-dione, 11,17,21-trihydroxy- (11β), is an anti-inflammatory corticosteroid.
Its empirical formula is C 21 H 30 O 5 . The structural formula is provided in Figure 2: Figure 2: Structural Formula of Hydrocortisone Structural Formula of Acyclovir Structural Formula of Hydrocortisone
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). General Patients should be informed that XERESE is not a cure for cold sores. Patients should be instructed that XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth.
Patients should be advised that XERESE should not be used in the eye, inside the mouth or nose, or on the genitals. Instructions for Use Advise patients to apply XERESE topically 5 times per day for 5 days. Instruct patients to topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin.
Advise patients to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada Product under license from Meda Pharma S.A.R.L., Luxembourg by Bausch Health Ireland Limited, Dublin, Ireland U.S.
Patent Number: 7,223,387 XERESE is a trademark of Meda Pharma S.A.R.L. used under license. Zovirax is a registered trademark of the GlaxoSmithKline group of companies. © 2020 Bausch Health Companies Inc. or its affiliates 9587303