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ABREVA

docosanol · Cream

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ABREVA
Generic name
docosanol
Dosage form
Cream
Route
Topical
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
6
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Docosanol 100 mg/g 797534 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Topical
Presentations
8

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020941
Application type
NDA · New Drug Application
Approval date
July 25, 2000
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
9
Products approved under application 020941.
Product Trade name Form Strength Ingredient Status TE Flags
020941-001 ABREVA CREAM DOCOSANOL Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020941.
Type No. Action Status Date Review
Supplement 17 Labeling Approved April 14, 2026 Standard
Supplement 12 Labeling Approved January 10, 2017 Standard
Supplement 11 Labeling Approved January 30, 2015 Standard
Supplement 9 Manufacturing (CMC) Approved February 8, 2008 N/A
Supplement 6 Manufacturing (CMC) Approved May 23, 2007 N/A
Supplement 3 Manufacturing (CMC) Approved December 13, 2002 Standard
Supplement 2 Manufacturing (CMC) Approved September 18, 2001 Standard
Supplement 1 Manufacturing (CMC) Approved March 12, 2001 Standard
Original application 1 Type 1 - New Molecular Entity Approved July 25, 2000 Standard

Review documents

  • 0 · Supplement · April 27, 2026
  • 0 · Supplement · April 20, 2026
  • 0 · Supplement · January 24, 2017
  • 0 · Supplement · January 18, 2017
  • 0 · Supplement · February 17, 2015
  • 0 · Supplement · February 2, 2015
  • 0 · Supplement · February 14, 2008
  • 0 · Supplement · May 29, 2007
  • 0 · Supplement · May 29, 2007
  • 0 · Original application · August 21, 2001
  • 0 · Original application · July 25, 2000
  • 0 · Original application · July 25, 2000

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240620). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240620

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Cold sore/fever blister treatment

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years or over : wash hands before and after applying cream apply to affected area on 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

openFDA Drug Labeling

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 Do not use if you are allergic to any ingredient in this product When using this product apply only to affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread infection. Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

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

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days

Active Ingredient

openFDA Drug Labeling

Active ingredient Docosanol 10%

Adverse event reports

Source: openFDA FAERS
14,572
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DOCOSANOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0135-0200-01 0135-0200 Haleon US Holdings LLC 2 g in 1 TUBE (0135-0200-01) March 19, 2010
0135-0200-03 0135-0200 Haleon US Holdings LLC 2 g in 1 BOTTLE, PUMP (0135-0200-03) March 19, 2010
0135-0200-05 0135-0200 Haleon US Holdings LLC 2 TUBE in 1 PACKAGE (0135-0200-05) / 2 g in 1 TUBE July 6, 2017
0135-0200-06 0135-0200 Haleon US Holdings LLC 3 BOTTLE, PUMP in 1 PACKAGE (0135-0200-06) / 2 g in 1 BOTTLE, PUMP January 2, 2024
0135-0300-01 0135-0300 Haleon US Holdings LLC 1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE March 25, 2022
0135-0300-02 0135-0300 Haleon US Holdings LLC 2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE April 25, 2022
0135-0200 0135-0200 Haleon US Holdings LLC — March 19, 2010
0135-0300 0135-0300 Haleon US Holdings LLC — March 25, 2022

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.