Docosanol: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: December 29, 2025🚩 Report this page

Docosanol

Antivirals

Sold as Cold Sore Treatment · Julie Cold Sore Treatment · Cold Sore Fever Blister…

US FDAGB MHRA

Drug class: Antivirals
Availability: Over-the-counter
Routes: Topical
Markets covered: 2
Products on record: 9
FDA reports (12 mo): 136

Overview

Docosanol is an active pharmaceutical ingredient in the Antivirals group (D06BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	7	December 29, 2025
GB United Kingdom	MHRA	2	December 5, 2025

USUnited States· FDA

7 products

Uses

USOfficial regulatory label· revised October 17, 2024[1]

Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching

How to take

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised December 5, 2025[2]

Treatment of early stages (prodrome or erythema phase) of recurrent labial herpes simplex infection (coldsores) in immunocompetent patients.

How to take

Sources & citations

[1]FDA DailyMed · 07fc9c8d-dee7-4a… · revised October 17, 2024 [PDF]
[2]MHRA (UK) · PL535120002 · revised December 5, 2025
[3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised December 5, 2025[2]

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data). Results from clinical trials of the treatment of recurrent labial herpes simplex demonstrate no difference in the frequency or type of undesirable effects in patients treated with Blistex Cold Sore Cream or placebo.
7% of placebo-treated patients). 3% of placebo- treated patients). Facial oedema has also been reported but these application site adverse reactions are consistent with normal facial reactions experienced with cold sores. Reporting of suspected adverse reactions Reporting suspected adverse actions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised December 5, 2025[2]

Avoid application close to or in the eyes. Should only be used for cold sores on the mouth and face. Must not be used to treat genital or ocular herpes infections Avoid transmitting the virus, particularly when active lesions are present The cream should not be used in immuno compromised patients.
Treatment with the cream should not be initiated at the stage of an already developed blister or ulcer. If the recurrent cold sore is particularly severe, consult doctor. Immunocompromised patients should consult a pharmacist or doctor concerning treatment of any infection, including cold sores.
Pediatric population There is no treatment experience available for the use in children below the age of 12 years and only limited experience in adolescent(aged12-18years). It is recommended that the cream should not be used in children under 12 years.
This formulation contains propylene glycol and may cause skin irritation.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

USUnited States· FDA

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations