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Docosanol

Docosanol is a topical cream used to treat cold sores (fever blisters) on the face or lips and shorten healing time and symptoms.

Brand names AbrevaCold Sore Fever Blister TreatmentCold Sore TreatmentCold Sore Fever BlisterCold Sore Treatment Docosanol +2 more
OTC Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 73 clinical label sets 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 →

✓No current FDA shortage listed · checked Oct 8, 2026
Docosanol at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Docosanol (Abreva) is the most familiar over-the-counter cream for cold sores (fever blisters) on the face or lips, working by keeping the virus out of healthy skin cells, and after more than a decade on shelves it is available as a generic. It is very gentle, and most people notice nothing beyond the cream itself, but the payoff is modest: a somewhat shorter cold sore with less tingling, pain, burning and itching, and only if you start at the first tingle. Stop it and get help right away for hives, facial swelling or trouble breathing, and see a doctor if the sore worsens or lingers past 10 days.

Clinical pearls

  • Keep your own tube handy if cold sores keep coming back, since starting at the very first tingle matters most.
  • Never share the tube, and wash your hands after each application so the virus does not travel to your eyes.
  • It belongs on the outside of the lips and face only, never inside the mouth or near the eyes.
  • If a child swallows some, call Poison Control right away, and ask a doctor before using it on children under 12.
How you get itOver the counter
Comes asTopical cream, ointment or gel
Earliest FDA record2000
Companies listing it with the FDA41
FDA label last updatedJun 20, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Docosanol, written from its FDA label.

What Docosanol is used for

▾

Docosanol cream is used for cold sores.

  • Treats cold sores/fever blisters on the face or lips (Abreva, Amazon Basics Docosanol, Cold Sore Treatment Docosanol, Cold Sore Fever Blister Treatment, Cold Sore Treatment and Cold Sore Fever Blister creams)
  • Shortens healing time and how long symptoms last
  • Symptoms include tingling, pain, burning and itching

Docosanol dosage

▾

Docosanol is a cream applied to the skin. Start at the first sign of a cold sore, such as a tingle, because early treatment gives the best results.

  • Adults and children 12 and older: wash your hands before and after applying.
  • Rub it in gently but completely.
  • Use it 5 times a day until healed.
  • Children under 12: ask a doctor.

Follow the product label and your prescriber or pharmacist.

Dosing details from the FDA-approved label

From the Docosanol 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.

  • Adults and children 12 years or over (cold sore/fever blister on face or lips)
    • Wash hands before and after applying cream
    • Apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle)
    • Early treatment ensures the best results
    • Rub in gently but completely
    • Use 5 times a day until healed
  • Children under 12 years
    • Ask a doctor
Read the label’s full dosing text

Directions • adults and children 12 years or over: • wash hands before and after applying cream • apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle). • early treatment ensures the best results • rub in gently but completely • use 5 times a day until healed • children under 12 years: ask a doctor Other information • store at 20° to 25°C (68° to 77°F). • do not freeze

Read the full Dosage and Administration section on DailyMed →

Docosanol side effects

▾

The label does not list specific common side effects, but allergic reactions can happen.

    Stop use and get medical help right away for hives, facial swelling, wheezing or trouble breathing, shock, or rash.

    Docosanol warnings and precautions

    ▾
    • Severe allergic reaction is possible. Stop use and get medical help right away.
    • For external use only.
    • Apply only to affected areas. Keep it out of and away from the eyes, and avoid applying directly inside your mouth.
    • Do not share it. This may spread the infection.
    • Ask a doctor if the cold sore gets worse or is not healed within 10 days.
    • Keep it out of reach of children. If swallowed, get medical help or call Poison Control.

    Before taking Docosanol

    ▾
    • Do not use it if you are allergic to any ingredient in the product.
    • Children under 12 should only use it after asking a doctor.
    • Do not use it in or near the eyes.

    Docosanol overdose

    ▾

    If the cream is swallowed, get medical help or contact a Poison Control Center right away.

    How to store Docosanol

    ▾

    store at 20 o -25 o C (68 o -77 o F) do not freeze

    Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

    Docosanol: pharmacist answers to common questions

    Quick, plain-English answers to the questions patients ask most about Docosanol — the kind of thing our pharmacy team would talk through with you at the counter.

    What is Docosanol for?

    ▾
    It treats cold sores, also called fever blisters, on your face or lips. It can shorten healing time and how long tingling, pain, burning and itching last.

    When should I start using it?

    ▾
    Start at the very first sign, usually a tingle. Early treatment gives the best results. Wash your hands before and after, then rub it in gently but completely.

    How often do I apply it?

    ▾
    Adults and children 12 and older use it 5 times a day until the cold sore heals. If your child is under 12, check with a doctor first.

    Are there any warnings I should know about?

    ▾
    It can rarely cause a severe allergic reaction, with hives, facial swelling, wheezing, rash or trouble breathing. If that happens, stop and get medical help right away. Do not use it if you are allergic to any ingredient.

    Where shouldn't I put it?

    ▾
    Use it only on the affected areas of your face or lips. Keep it out of and away from your eyes, and avoid putting it directly inside your mouth. It is for external use only.

    When should I see a doctor?

    ▾
    See one if your cold sore gets worse or is not healed within 10 days. Also don't share the product, since that may spread the infection.

    Is Docosanol available over the counter?

    ▾
    Yes. The Docosanol products listed with the FDA are sold over the counter, without a prescription (the topical cream, ointment or gel form). Follow the package directions. Your pharmacist can tell you which product is right for you.

    When was Docosanol first available?

    ▾
    The earliest FDA record we hold for Docosanol is from 2000: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Docosanol was first used.

    Who makes Docosanol?

    ▾
    41 companies currently list Docosanol products in the FDA's NDC Directory, including P & L Development, LLC, WALMART INC. (see also Equate), Walgreens. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

    Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

    More about Docosanol on HelloPharmacist

    Detailed data & references for Docosanol Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

    Docosanol forms and strengths (how it comes)

    Docosanol 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 Docosanol inactive ingredients by manufacturer.

    Topical cream, ointment or gel

    By mouth · On the skin
    Brands Abreva Amazon Basics Docosanol Cold Sore Fever Blister Cold Sore Fever Blister Treatment Cold Sore Treatment Cold Sore Treatment Docosanol Julie Cold Sore Treatment
    How this form is used
    What it may be used for
    • Abreva cream treats cold sores/fever blisters on the face or lips.
    • Abreva cream shortens healing time and duration of symptoms such as tingling, pain, burning and itching.
    • Cold Sore Treatment Docosanol cream treats cold sores/fever blisters on the face or lips.
    Important instructions
    • Abreva cream: adults and children 12 and older wash hands before and after, apply at the first tingle, rub in gently but completely, and use 5 times a day until healed.
    • Abreva cream: for children under 12, ask a doctor.
    • Amazon Basics Docosanol cream: store at 20° to 25°C (68° to 77°F) and do not freeze.
    Available strengths 1 strength
    131 FDA-listed product records ⓘ

    Docosanol on the U.S. market: products, makers and brands

    How Docosanol 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.

    41 companies list 73 Docosanol product records with the FDA, mostly as topical cream, ointment or gel; the earliest marketing or approval year on record is 2000. Brand names on the directory include Abreva, Cold Sore Fever Blister Treatment, Cold Sore Treatment and 4 more; the rest are generics.

    1
    Dose forms ⓘ
    41
    Labelers (makers, repackagers, distributors)
    8
    Brand names
    73
    FDA-listed product records ⓘ
    2000
    Earliest FDA record ⓘ

    Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

    P & L Development, LLC7%
    WALMART INC. (see also Equate)7%
    Walgreens7%
    H E B5%
    Care One (Retail Business Services, LLC.)4%
    Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)4%
    Other makers66%

    Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    How widely Docosanol is used (Medicaid data)

    A general measure of how commonly Docosanol 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 Docosanol 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.

    4,506
    Medicaid prescriptions filled (Q1–Q4 2025)
    $94,756 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Docosanol prescribed? Of the 1,601 medications we measure, Docosanol ranks #1,062 by Medicaid prescriptions — more than 34% of them.

    Where Docosanol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

    Utilization by Docosanol 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.

    docosanol 100 MG/ML Topical Cream

    4,506 Medicaid prescriptions (Q1–Q4 2025) 100% of Docosanol prescriptions shown $94,756 gross reimbursement (before rebates) ≈ $21 per prescription (gross)

    Summed across the 6 of 117 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 797534

    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 Docosanol, 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 6 of 117 listed Docosanol NDCs with Medicaid activity.

    Compare Docosanol products

    A representative set of FDA-listed product records for Docosanol — 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.)

    Showing 73 of 73 products — FDA National Drug Code Directory. See every product, package size and price: browse all 73 Docosanol NDCs →

    Docosanol 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 Docosanol — a signal of what to watch for, not proof the drug caused it.

    The effects most often named in FDA reports that mention Docosanol are oral herpes, condition aggravated, incorrect drug administration duration; about 2% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

    14,572
    Reports mentioning it
    2%
    Reported as serious
    12
    Distinct effects shown
    Most reported effects
    Oral Herpes
    2,456
    Condition Aggravated
    1,965
    Incorrect Drug Administration Duration
    803
    Herpes Simplex
    706
    Incorrect Product Administration Duration
    639
    Lip Swelling
    559
    Product Quality Issue
    539
    Inappropriate Schedule Of Drug Administration
    493
    Application Site Pain
    445
    Product Complaint
    374
    Age groups
    Adult · 136Elderly · 45Child · 4Adolescent · 1

    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 Docosanol 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.

    Docosanol FDA approval history

    How Docosanol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

    Docosanol was first approved by the FDA in 2000 (Brand: ABREVA · Haleon Us Holdings); the first generic version was approved in 2018. It remains available in U.S. pharmacies today.

    2000
    Brand approved
    Brand: ABREVA · Haleon Us Holdings
    2018
    First generic approved
    Lower-cost ANDA competition begins
    2026
    Available today
    Active in U.S. pharmacies

    Source: Drugs@FDA.

    Docosanol 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 Docosanol recalls since July 2021.

    ✅No Docosanol recalls on record since July 2021

    Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

    RxNorm Concept Web — From Ingredient to Every Form and Strength

    This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

    Ingredient (IN) Docosanol RxCUI 594680 1 dose form · 1 strength
    1. Dose form (SCDF) Topical Cream RxCUI 797533 In current FDA listings
      Clinical drug / strength (SCD) 100 MG/ML RxCUI 797534

    Look up RxCUI 594680 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.

    Docosanol brand names

    Docosanol is sold under 7 brand names in the FDA directory — Abreva, Cold Sore Fever Blister Treatment, Cold Sore Treatment, Cold Sore Fever Blister and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

    Abreva Cold Sore Fever Blister Treatment Cold Sore Treatment Cold Sore Fever Blister Cold Sore Treatment Docosanol Amazon Basics Docosanol Julie Cold Sore Treatment

    Who makes Docosanol: manufacturers and labelers

    41 companies list Docosanol products with the FDA. By number of product records, the largest are P & L Development, LLC, WALMART INC. (see also Equate), Walgreens. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

    P & L Development, LLC 5 WALMART INC. (see also Equate) 5 Walgreens 5 H E B 4 Care One (Retail Business Services, LLC.) 3 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3 FSA Store Inc. (Caring Mills) 3 Safeway, Inc. 3 AAFES/Your Military Exchanges 2 H2-Pharma, LLC 2 Haleon US Holdings LLC 2 Leader/ Cardinal Health 110, Inc. 2 Meijer Distribution Inc. 2 Strategic Sourcing Services LLC 2 TARGET Corporation 2 The Kroger Co. 2 Topco Associates 2 Alembic Pharmaceuticals Inc. 1 Alembic Pharmaceuticals Limited 1 Amazon.com Services LLC 1 Amerisource Bergen 1 Aurohealth LLC 1 Best Choice (Valu Merchandisers Company) 1 Blistex Inc. 1

    …and 17 more on the FDA NDC directory.

    Docosanol drug class (RxNorm)

    Docosanol belongs to the Antivirals class.

    Drug family (ATC) Antivirals

    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 Docosanol 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.

    📄
    FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 20, 2024
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Docosanol.
    📈
    Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
    🚨
    Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
    🧾 Clinical label set — FDA-filed SPL labels retained for Docosanol after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    73
    Finished products in the current FDA directory
    73
    Companies listing them (makers, repackagers, distributors)
    41
    FDA labeler codes behind them ⓘ
    41
    Linked representative label ⓘ
    GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
    Linked label effective
    Jun 20, 2024
    Composite sections available
    7
    Linked SPL Set ID
    c39b38a7-dcdd-4c32-8f35-b565c4d3cec6
    Linked SPL Document ID
    1b525ee7-41df-5a73-e063-6294a90a0b86
    Open the linked representative label on DailyMed ↗

    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. GlaxoSmithKline Consumer Healthcare Holdings (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 →