ADD CONDITION

items per page

Docosanol

Last content change checked dailysee data sync status

Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
December 25, 2025
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
Marketed in the U.S.
Since 2024
Label revision date
December 25, 2025
Manufacturer
Leader/ Cardinal Health 110, Inc.
Registration number
ANDA215839
NDC roots
70000-0672, 70000-0743

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 on the face or lips. It works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching. This cream is the only non-prescription cold sore treatment approved by the FDA for these purposes, making it a reliable option for managing outbreaks.

When applied topically, Docosanol Cream helps to alleviate the discomfort associated with cold sores, allowing you to feel more comfortable while the sore heals. If you're looking for an effective way to address cold sores, this cream may be a suitable choice for you.

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 shortens the healing time and reduces the duration of symptoms like tingling, pain, burning, and itching.

You can expect relief from these symptoms, allowing you to feel more comfortable and get back to your daily activities more quickly. Rest assured, there are no concerns about teratogenic effects (which means it doesn’t cause birth defects) associated with this treatment.

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 often to take it, or how to apply 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.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. They can provide personalized advice and address any concerns you may have.

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, stop using the product and consult your doctor. It's important to be aware of these potential side effects to ensure your safety while using this medication.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or rash, stop using the product immediately and seek medical help. It’s important not to use this product if you are allergic to any of its ingredients.

When applying the product, make sure to use it only on the affected areas and avoid contact with your eyes or applying it inside your mouth. Do not share this product with others, as this can spread the infection. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using Docosanol Cream during pregnancy, there is currently no specific information available about its safety or effectiveness. This means that there are no known safety concerns, dosage changes, or special precautions outlined for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter products like Docosanol Cream. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding, you can use Docosanol Cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing risks to your nursing infant.

As always, if you have any questions or concerns about using this product 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. Starting treatment early is key to achieving the best results. Make sure to rub the cream 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 the cream is swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 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 want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using 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 the medication topically to the affected area on your face or lips as soon as you notice the first signs of a cold sore, such as tingling. Use it five times a day until the sore is healed. If your cold sore worsens or does not heal within 10 days, stop using the product and consult a doctor. Additionally, if you experience any allergic reactions, discontinue use immediately and seek medical assistance.

Keep this medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center right away.

FAQ

What is Docosanol Cream used for?

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

How does Docosanol Cream work?

It shortens the healing time and duration of symptoms such as tingling, pain, burning, and itching.

Is Docosanol Cream available by prescription?

No, Docosanol Cream is a non-prescription medicine.

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.

How should I apply Docosanol Cream?

Apply the cream to the affected area on the face or lips at the first sign of a cold sore, using it 5 times a day until healed.

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

Stop using the cream and consult a doctor if your cold sore worsens or does not heal within 10 days.

Can I use Docosanol Cream if I am pregnant or nursing?

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

What are the storage instructions for Docosanol Cream?

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

Who should not use Docosanol Cream?

Do not use this product if you are allergic to any ingredient in it.

Is there any information on drug interactions with Docosanol Cream?

No specific drug interaction information is provided for Docosanol Cream.

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 located on the face or lips. It is effective in shortening the healing time and reducing the duration of associated symptoms, which may include tingling, pain, burning, and/or itching.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Therefore, no specific instructions regarding avoidance or non-use are necessary.

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 with others 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. Regular monitoring of the patient's condition is recommended to ensure appropriate management and intervention if necessary.

Side Effects

Patients may experience a range of adverse reactions associated with this product. A severe allergic reaction is a notable concern, with symptoms that may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. Due to the potential for such reactions, individuals who are allergic to any ingredient in this product are advised not to use it.

In clinical practice, it is important for patients to monitor their condition closely. If a cold sore worsens or does not heal within 10 days, patients should discontinue use and consult a healthcare professional for further evaluation and guidance.

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, the recommended application involves washing hands before and after applying the cream to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Early treatment is crucial for optimal results. The cream should be gently but completely rubbed in and applied five times a day until healing occurs.

It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 is currently no information available regarding the use of Docosanol Cream during pregnancy. The prescribing information does not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant individuals. Women of childbearing potential should be counseled accordingly, given the lack of data on fetal outcomes associated with Docosanol Cream.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the individual and the circumstances surrounding the event. In cases where an overdose is suspected, it is recommended to monitor the patient closely for any adverse effects or unusual symptoms that may arise.

Management of an overdose should be initiated promptly. Healthcare professionals are advised to contact a poison control center or seek guidance from a medical toxicologist for specific recommendations tailored to the situation. Supportive care should be provided as necessary, and symptomatic treatment should be administered based on the clinical presentation of the patient.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and implement appropriate management strategies in the event of an overdose.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided for Docosanol Cream, 10%.

Patient Counseling

Healthcare providers should advise patients on the proper storage conditions for their medication. Patients should be instructed to store the medication at a temperature range of 20° to 25°C (68° to 77°F). It is important to emphasize that the medication should not be frozen, as freezing may compromise its effectiveness. Providers should ensure that patients understand the significance of adhering to these storage guidelines to maintain the integrity of the medication.

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 efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness throughout its shelf life.

Additional Clinical Information

The product is administered topically, applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Patients are advised to use the treatment five times a day until the lesion is healed.

Clinicians should counsel patients to discontinue use and seek medical advice if the cold sore worsens or does not heal within 10 days. Additionally, if an allergic reaction occurs, patients should stop using the product and seek immediate medical assistance. It is important to keep the product out of reach of children, and in the event of ingestion, medical help or contact with a Poison Control Center should be sought promptly.

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.