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Docosanol

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Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
March 13, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
March 13, 2026
Manufacturer
CVS Pharmacy, Inc.
Registration number
ANDA215839
NDC root
51316-763
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Docosanol Cream, 10% is a non-prescription medication specifically designed to treat cold sores and fever blisters. It is the only non-prescription cold sore treatment approved by the FDA to help shorten the healing time and reduce the duration of symptoms. This cream works topically, meaning it is applied directly to the affected area to provide relief.

You can find Docosanol Cream available in various packaging options, including pump packs and tubes. It is important to note that this product is not manufactured or distributed by GSK Consumer Healthcare, the company behind Abreva®, which contains a similar active ingredient.

Uses

If you're dealing with cold sores or fever blisters, this medication can help. It's specifically designed to treat these conditions and is the only non-prescription medicine approved by the FDA that can shorten both the healing time and the duration of symptoms.

You can use it topically, meaning you apply it directly to the affected area. This treatment is effective for managing cold sores, helping you feel better faster.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs. Always follow their instructions for the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

This product may cause a severe allergic reaction, which can include symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you are allergic to any ingredient in this product, you should not use it.

If your cold sore worsens or does not heal within 10 days, it’s important to stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. Symptoms of an allergic reaction can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, stop using the product immediately and seek medical help.

Make sure to apply the product only to the affected areas and avoid using it near your eyes or inside your mouth. Do not share this product with others, as it may spread the infection. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. If the product is swallowed, seek medical assistance or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, you can use Docosanol Cream without specific warnings or contraindications noted in the information provided. This means that, based on the available data, there are no known risks associated with using this cream during your pregnancy. However, it's always a good idea to consult with your healthcare provider before starting any new medication or treatment to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Docosanol Cream without specific warnings or recommendations against it. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using new products while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this cream. For children aged 12 and older, you should wash your hands before and after applying the cream. Apply it to the affected area on the face or lips as soon as you notice the first signs of a cold sore or fever blister, such as a tingling sensation. Starting treatment early can lead to the best results. Make sure to rub the cream in gently but completely, and use it five times a day until the area is healed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep them informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to avoid freezing the product, as this can affect its effectiveness and safety.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any additional safety instructions provided with the product to ensure safe and effective use.

Additional Information

No further information is available.

FAQ

What is Docosanol Cream used for?

Docosanol Cream is used for the treatment of cold sores and fever blisters.

How does Docosanol Cream work?

It is a non-prescription medicine approved by the FDA to shorten the healing time and duration of cold sore symptoms.

Is there any specific dosage information for Docosanol Cream?

The provided information does not include specific dosage and administration details.

What should I do if I experience an allergic reaction?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using the product and seek medical help immediately.

Can I use Docosanol Cream if I am pregnant?

There are no specific warnings or contraindications regarding the use of Docosanol Cream during pregnancy.

How should I apply Docosanol Cream?

You should apply it to the affected area on your face or lips at the first sign of a cold sore, using it five times a day until healed.

What should I do if my cold sore does not heal?

If your cold sore worsens or does not heal within 10 days, stop using the product and consult a doctor.

Where can I purchase Docosanol Cream?

Docosanol Cream is distributed by CVS Pharmacy, Inc. and can be found at their locations or online.

What are the storage conditions for Docosanol Cream?

Store Docosanol Cream at 20° to 25°C (68° to 77°F) and do not freeze.

Packaging Info

Below are the non-prescription pack sizes of Docosanol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Docosanol.
Details

Drug Information (PDF)

This file contains official product information for Docosanol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Docosanol Cream is formulated with 10% docosanol as the active ingredient. It is presented in a cream dosage form.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters. It is a non-prescription medicine specifically formulated to shorten the healing time and duration of symptoms associated with cold sores. This formulation contains the only non-prescription cold sore medicine approved by the FDA for this purpose.

This drug is intended for topical use only. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

There is currently no specific dosage and administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route of administration, and frequency of use. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

This product has the potential to induce severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product is intended for external use only. It is contraindicated for individuals with known allergies to any of its ingredients.

When administering this product, it is essential to apply it solely to the affected areas. Care should be taken to avoid contact with the eyes and to refrain from applying the product directly inside the mouth. Additionally, sharing this product is strongly discouraged, as it may facilitate the spread of infection.

Healthcare professionals should advise patients to discontinue use and consult a physician if the cold sore worsens or fails to heal within 10 days. In cases of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a potential for severe allergic reactions, which may manifest as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. Due to this risk, individuals with known allergies to any ingredient in this product are advised not to use it.

In clinical practice, patients are instructed to discontinue use and consult a healthcare professional if their cold sore worsens or fails to heal within 10 days. This precaution is essential to ensure appropriate management and to mitigate any potential complications arising from the use of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Docosanol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Docosanol.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, it is recommended to wash hands before and after applying the cream. The cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Early treatment is essential for optimal results. The cream should be rubbed in gently but completely and used five times a day until healing is achieved.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or contraindications regarding the use of Docosanol Cream during pregnancy. Available data do not indicate any known risks associated with the use of this medication in pregnant patients. However, as with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when prescribing Docosanol Cream to women of childbearing potential. It is advisable to monitor for any adverse effects in both the mother and fetus during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of Docosanol Cream in lactating mothers. Additionally, there is no information available about the potential for excretion of Docosanol in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to address any complications that may arise during the management of an overdosage.

In summary, swift action and appropriate medical guidance are vital in the event of an overdosage to ensure patient safety and effective treatment.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to ensure that the product does not freeze, as this may compromise its integrity. Proper storage conditions are essential to maintain the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Docosanol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Docosanol, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.