Docosanol
/api/v1/drug/docosanolIndications
Sourced from openFDA- Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itchingICD-10: B00.9
Dosage & administration
Sourced from openFDADirections adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the 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
Warnings & precautions
Sourced from openFDAAllergy Alert: This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only
Approval history
Sourced from openFDA- Jul 25, 2000NDANDA020941Haleon Us Holdings
- Nov 19, 2018ANDAANDA208754P And L
- May 3, 2022ANDAANDA215839Alembic
- Oct 7, 2022ANDAANDA212385P And L Development
- Oct 26, 2023ANDAANDA214454Sun Pharma Canada
- Mar 1, 2024ANDAANDA217090Aurobindo Pharma Ltd
FAERS reports
- 1Drug Ineffective7,03248%
- 2Oral Herpes2,44917%
- 3Condition Aggravated1,95713%
- 4Drug Administration Error1,77912%
- 5Incorrect Drug Administration Duration8035.5%
- 6Herpes Simplex7064.9%
- 7Incorrect Product Administration Duration6374.4%
- 8Lip Swelling5563.8%
- 9Wrong Technique In Product Usage Process5513.8%
- 10Product Quality Issue5393.7%
- 11Inappropriate Schedule Of Drug Administration4933.4%
- 12Application Site Pain4453.1%
- 13Inappropriate Schedule Of Product Administration3992.7%
- 14Product Complaint3742.6%
- 15Hypersensitivity3182.2%
Clinical trials
The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Docosanol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus EruptionsCompleted · Phase 2 · Interventional · 40 enrolled · University of UtahNCT06558838updated 2026-01-05
- EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus EruptionsCompleted · Phase 2 · Interventional · 10 enrolled · University of UtahNCT04893577updated 2025-10-31
- Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin TreatmentCompleted · Phase 3 · Interventional · 36 enrolled · Indonesia UniversityNCT06178367updated 2024-04-30
- A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin AgingCompleted · Interventional · 35 enrolled · Dime Beauty Co.NCT06125912updated 2024-02-22
- Topical and Oral Regimen for Skin HealthCompleted · Interventional · 74 enrolled · Integrative Skin Science and ResearchNCT04872946updated 2021-05-05
- An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes LabialisUnknown · Phase 2 · Interventional · 164 enrolled · Laboratoire Boreaderme Inc.NCT03977792updated 2020-09-07
- Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)Unknown · Phase 4 · Interventional · 75 enrolled · Hadassah Medical OrganizationNCT00467662updated 2007-05-01
Frequently asked questions
- What is Docosanol used for?
- According to FDA labeling, Docosanol carries indications including: Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Docosanol?
- Docosanol is classified as Antivirals.
- What are the brand names for Docosanol?
- Docosanol is marketed under brand names including Abreva.
docosanol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.