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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 2025
Label revision date
February 18, 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 2025
Label revision date
February 18, 2026
Manufacturer
WALMART INC. (see also Equate)
Registration number
ANDA208754
NDC root
79903-402
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 is a topical cream that is used to treat cold sores and fever blisters on the face or lips. It works by shortening the healing time and reducing the duration of symptoms, which can include tingling, pain, burning, and itching. As a non-prescription medicine, it is designed for easy access and can help you manage the discomfort associated with cold sores effectively.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, this medication can help. It not only treats these uncomfortable sores but also works to shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching.

By using this treatment, you can expect relief from the discomfort associated with cold sores, allowing you to feel more like yourself again.

Dosage and Administration

Before using the cream, make sure to wash your hands thoroughly. When you notice the first signs of a cold sore or fever blister, such as a tingling sensation, apply the cream directly to the affected area on your face or lips. It's important to start treatment as early as possible for the best results. Gently rub the cream into the skin until it is fully absorbed.

For adults and children aged 12 years and older, you should apply the cream five times a day until the cold sore is healed. If you are considering using this cream for a child under 12, please consult a doctor first for guidance. Remember to wash your hands again after applying the cream to avoid spreading the virus.

What to Avoid

It's important to be aware of certain precautions when using this product. First and foremost, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, avoid applying the product in or near your eyes and do not use it directly inside your mouth. Sharing this product with others is also discouraged, as it can spread infections.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any concerns or questions, please consult with a healthcare professional.

Side Effects

This product may cause a severe allergic reaction in some individuals. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, it is important to seek medical attention immediately.

Additionally, if your cold sore worsens or does not heal within 10 days, you should stop using the product and consult your doctor for further guidance.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some individuals. 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.

Before using this product, ensure you are not allergic to any of its ingredients. If your cold sore worsens or does not heal within 10 days, stop using the product and contact your doctor for further advice.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

Currently, there is no information available about the use of Docosanol Cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is 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, if you have concerns or questions about using any medication while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this cream. For those 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, like a tingling sensation. Early treatment is key for the best results. Make sure to rub it in gently and completely, using it five times a day until the area is healed.

Always keep this cream out of reach of children. If it is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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, it’s important to consult with a healthcare provider for personalized advice. 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, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for the medication may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while taking any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should apply this medication topically to the affected area on your face or lips as soon as you notice the first signs of a cold sore or fever blister, such as tingling. For best results, use it five times a day until the sore is healed. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available.

FAQ

What is Docosanol used for?

Docosanol is a cream used to treat cold sores and fever blisters on the face or lips.

How does Docosanol work?

It shortens the healing time and duration of symptoms, which include tingling, pain, burning, and/or itching.

How should I apply Docosanol?

Wash your hands before and after applying the cream to the affected area at the first sign of a cold sore. Rub it in gently and use it 5 times a day until healed.

Can children use Docosanol?

Docosanol is for adults and children 12 years or older. For children under 12, you should ask a doctor.

What precautions should I take when using Docosanol?

Do not use it in or near the eyes, avoid applying it directly inside your mouth, and do not share the product with others.

What should I do if I experience an allergic reaction?

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

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

If your cold sore gets worse or is not healed within 10 days, stop using the product and ask a doctor.

How should I store Docosanol?

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

Is there any information about using Docosanol during pregnancy or while nursing?

There is no specific information regarding the use of Docosanol during pregnancy or nursing.

What should I do if Docosanol is swallowed?

If swallowed, get medical help or contact a Poison Control Center immediately.

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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters on the face or lips. It is effective in shortening the healing time and reducing the duration of associated symptoms, including tingling, pain, burning, and itching.

Dosage and Administration

Healthcare professionals should instruct patients to wash their hands thoroughly before and after applying the cream. For adults and children aged 12 years and older, 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, such as a tingling sensation. Early treatment is crucial for achieving optimal results. The cream should be rubbed in gently but completely, and it is recommended to apply the cream five times a day until the lesion is healed.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any ingredient contained within.

Additionally, the product should not be applied in or near the eyes, nor should it be applied directly inside the mouth. Sharing this product with others is also contraindicated, as it may facilitate the spread of infection.

Warnings and Precautions

This product carries a significant risk of 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.

For external use only, this product should not be administered to individuals with known allergies to any of its ingredients. It is essential to assess patient history for any potential allergic responses prior to recommending this product.

Patients should be advised to discontinue use and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days. This precaution is critical to ensure appropriate management and to prevent complications.

In cases of accidental ingestion, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay.

Side Effects

Patients may experience a range of adverse reactions associated with this product.

Serious Adverse Reactions A severe allergic reaction may occur, which can manifest as hives, facial swelling, wheezing or difficulty breathing, shock, or rash. Patients experiencing any of these symptoms should seek immediate medical attention.

Common Adverse Reactions Patients are advised to discontinue use and consult a healthcare professional if their cold sore worsens or does not heal within 10 days. This recommendation is based on clinical observations and is intended to ensure patient safety and effective management of symptoms.

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 associated with the best outcomes. The cream should be gently rubbed in completely and applied five times a day until healing occurs.

It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is currently no information available regarding the use of Docosanol Cream during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions thoroughly, as this information may be vital for ongoing patient management and for any necessary reporting to regulatory authorities.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product if they are allergic to any of its ingredients. It is important to counsel patients to stop using the product and consult a doctor if their cold sore worsens or does not heal within 10 days.

When using this product, patients should apply it only to the affected areas and avoid contact with the eyes. They should be cautioned against applying the product directly inside their mouth. Additionally, patients must be advised not to share this product with anyone, as this may facilitate the spread of infection.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and effectiveness. Proper storage conditions must be maintained to ensure the product's quality and safety.

Additional Clinical Information

The medication is administered topically, specifically applied to the affected area on the face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Patients are advised to use the treatment five times a day until the lesion is healed.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.