Drugplain

DOCOSANOL 100 mg/g

DOCOSANOL · CREAM · Amerisource Bergen

No Recall History
Plain English

Docosanol cream is a topical antiviral medication used to treat cold sores on the lips and face. Apply it directly to the affected area as directed on the package label to help shorten the duration and reduce symptoms of cold sore outbreaks.

Key Facts

Brand Name
DOCOSANOL
Generic Name
DOCOSANOL
NDC Code (Product)
46122-800
Manufacturer
Amerisource Bergen
Strength
100 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA217090
Marketing Start
10/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective384 reports
condition aggravated62 reports
product use in unapproved indication38 reports
oral herpes33 reports
incorrect product administration duration26 reports
drug effective for unapproved indication25 reports
product use issue19 reports
drug effect less than expected17 reports
lip swelling16 reports
wrong technique in product usage process15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions 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

Warnings Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty breathing shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only

Frequently Asked Questions

What is DOCOSANOL used for?

Docosanol cream is a topical antiviral medication used to treat cold sores on the lips and face. Apply it directly to the affected area as directed on the package label to help shorten the duration and reduce symptoms of cold sore outbreaks.

Is DOCOSANOL a controlled substance?

DOCOSANOL is not classified as a controlled substance by the DEA.

What is the generic name for DOCOSANOL?

The generic name for DOCOSANOL is DOCOSANOL. There are 11 other brand versions of DOCOSANOL.

What is the NDC code for DOCOSANOL 100 mg/g?

The NDC (National Drug Code) for DOCOSANOL 100 mg/g is 46122-800, listed by Amerisource Bergen.

Product NDC

46122-800

Package NDC

46122-800-36

Other DOCOSANOL Dosages

Other Docosanol Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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