FDA-filed SPL labeling · retrieved through openFDA

Docosanol

Docosanol is a topical antiviral ingredient used to treat cold sores and fever blisters on the face or lips, shortening healing time and relieving symptoms like tingling, pain, burning, and itching.

Brand names AbrevaCold Sore Fever Blister TreatmentCold Sore TreatmentCold Sore Fever BlisterAmazon Basics Docosanol +2 more
OTC Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 72 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 →

At a glance
Linked label effectiveJun 20, 2024
Clinical labels in scope ⓘ72
AvailabilityOTC
Earliest approval/marketing year ⓘ2000
FDA-listed product records ⓘ183
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 18, 2026
⭐ Docosanol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Docosanol cream is an over-the-counter treatment for cold sores and fever blisters on the face or lips. It works best when you start using it at the very first tingle — the earlier, the better. Apply it 5 times a day until healed, and see a doctor if the sore isn't better within 10 days.
How we write & review this content — our editorial policy →

📖 Docosanol: Patient Information Guide

A plain-language walkthrough of Docosanol — 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▾

Docosanol is an over-the-counter topical ingredient used specifically for cold sores and fever blisters.

  • Treats cold sores and fever blisters on the face or lips
  • Shortens the overall healing time of cold sores
  • Reduces the duration of symptoms: tingling, pain, burning, and itching
💊How it's taken▾

Docosanol cream is applied to the skin (topically) directly on the affected area of the face or lips. For adults and children 12 years and older, use it 5 times a day until the sore is fully healed. Start at the very first sign of a cold sore — the earlier you begin, the better your results.

  • Wash hands before and after every application
  • Apply only to the affected area; rub in gently but completely
  • Do not use in or near the eyes or directly inside the mouth
  • Children under 12: ask a doctor before use
🤒Side effects — in detail▾

Docosanol cream is applied to the skin, so most reactions happen at or near the application site. Common reactions reported include:

  • Skin rash
  • Hives
  • Itching or burning at the site
  • Facial swelling

Stop use immediately and get emergency medical help if you experience hives, facial swelling, wheezing, difficulty breathing, or shock — these are signs of a serious allergic reaction.

⚠️Warnings & precautions▾
  • Severe allergic reaction risk: This product can cause a serious allergic reaction with symptoms such as hives, facial swelling, wheezing, difficulty breathing, or shock. Stop use and seek emergency care right away if this happens.
  • For external use only — do not get in or near the eyes, and do not apply directly inside the mouth.
  • Do not share this product with anyone; sharing can spread the cold sore infection.
  • Stop use and see a doctor if the cold sore gets worse or hasn't healed within 10 days.
  • Keep out of reach of children. If swallowed, call Poison Control or get medical help immediately.
🔀What it interacts with▾

The FDA label for docosanol cream does not list specific drug, food, or supplement interactions.

    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▾
    • Do not use if you are allergic to any ingredient in this product
    • Children under 12 years old should not use this product without a doctor's guidance
    • Do not share the product with others — this can spread the cold sore infection
    🚑If you take too much▾

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

    📦How to store it▾

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

    📄 Written from Docosanol’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 Docosanol — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly does docosanol do for a cold sore? ▾
    Docosanol cream treats cold sores and fever blisters on the face or lips. It's designed to shorten how long the sore lasts and reduce those uncomfortable symptoms — the tingling, pain, burning, and itching. The key is starting it early, ideally the moment you feel that first tingle, before a full sore even appears.
    How often do I need to apply it, and for how long? ▾
    You apply it 5 times a day, every day, until the sore is completely healed. Don't stop early just because it looks better — keep going until it's fully healed. And remember to wash your hands both before and after you apply it.
    Is it safe for my child to use? ▾
    Docosanol cream is approved for adults and children 12 years and older. If your child is under 12, you need to check with their doctor before using it. Don't assume it's fine to use just because it's over the counter.
    Can I put it inside my mouth or near my eye? ▾
    No — this is for external use only. Keep it away from your eyes and avoid applying it directly inside your mouth. Only apply it to the affected area on your face or lips. If it gets in your eyes or is swallowed, contact Poison Control or get medical help right away.
    What should I watch for that means I need to stop using it? ▾
    Stop right away and get emergency help if you develop hives, swelling of your face, wheezing, trouble breathing, or go into shock — these can be signs of a serious allergic reaction. Also stop and call your doctor if your cold sore gets worse instead of better, or if it still hasn't healed after 10 days.
    Can I share this tube with a family member who also has a cold sore? ▾
    Please don't — the label specifically warns against sharing this product with anyone, because doing so can spread the infection. Each person should have their own tube.
    Is Docosanol available over the counter? ▾
    Yes — Docosanol is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
    When was Docosanol first available? ▾
    Docosanol has been available in the United States since at least 2000, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Docosanol? ▾
    Docosanol is supplied by 61 manufacturers listed in the FDA NDC Directory, including Walgreens, Rite Aid Corporation, P & L Development, LLC.

    💬 Answers drafted from Docosanol’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

    🌿Drug & Supplement CheckerDocosanol vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Docosanol NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

    💊 How Docosanol 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.

    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
    • Treats cold sores and fever blisters on the face or lips
    • Shortens healing time and reduces duration of symptoms including tingling, pain, burning, and itching
    Important instructions
    • Adults and children 12 and older: wash hands before and after applying; apply to the affected area at the first sign of tingling; rub in gently but completely; use 5 times a day until healed
    • Abreva: apply to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle); early treatment gives best results
    • Amazon Basics Docosanol: store at 68°–77°F (20°–25°C); do not freeze
    • Children under 12 years: ask a doctor before use
    Available strengths 1 strength
    100 mg/g
    178 FDA-listed product records ⓘ

    📊 Docosanol across the U.S. market

    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.

    1
    Dose forms ⓘ
    61
    Manufacturers
    8
    Brand names
    183
    FDA-listed product records ⓘ
    2000
    First marketed ⓘ

    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.

    Walgreens9%
    Rite Aid Corporation7%
    P & L Development, LLC5%
    Safeway, Inc.5%
    AAFES/Your Military Exchanges4%
    H E B4%
    Other makers65%

    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

    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 1,596 medications we measure, Docosanol ranks #1,060 by Medicaid prescriptions — more than 34% of them.

    Where Docosanol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #1,060 of 1,596
    #1,055 Trofinetide 4,625 Rx #1,056 Pilocarpine Ophthalmic 4,597 Rx #1,057 Malathion Topical 4,594 Rx #1,058 Betamethasone / Calcip... 4,570 Rx #1,059 Terbutaline 4,509 Rx #1,060 Docosanol 4,506 Rx #1,061 Tolmetin 4,475 Rx #1,062 Letermovir 4,462 Rx #1,063 Fidaxomicin 4,446 Rx #1,064 Galantamine 4,431 Rx #1,065 Mefloquine 4,419 Rx

    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 183 of 183 products — FDA National Drug Code Directory. See every product, package size and price: browse all 183 Docosanol NDCs →

    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.

    🏷️ Sold under these brand names

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

    🏭 Manufacturers & labelers

    Walgreens 15 Rite Aid Corporation 12 P & L Development, LLC 8 Safeway, Inc. 8 AAFES/Your Military Exchanges 7 H E B 7 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 7 The Kroger Co. 7 WALMART INC. (see also Equate) 6 TARGET Corporation 6 Chain Drug Consortium, LLC 6 Strategic Sourcing Services LLC 5 Care One (Retail Business Services, LLC.) 5 Meijer, Inc. 4 Meijer Distribution Inc. 4 H2-Pharma, LLC 4 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 4 Topco Associates 4 FSA Store Inc. (Caring Mills) 4 AmerisourceBergen (Good Neighbor Pharmacy) 46122 4 Family Dollar (FAMILY WELLNESS) 3 Best Choice (Valu Merchandisers Company) 3 United Natural Foods, Inc. dba UNFI 3 Cardinal Health (Leader) 70000 2

    …and 16 more on the FDA NDC directory.

    RxNorm drug class

    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.

    🔬 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.

    📄
    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
    72
    NDC products indexed
    183
    Distinct labelers/manufacturers represented
    61
    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 we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 72 FDA-filed SPL label sets 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. GlaxoSmithKline Consumer Healthcare Holdings (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.