ABREVA

Manufacturer
A-S Medication Solutions
Effective date
2021-04-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:39:44

Label at a glance#

ProductABREVA
Active ingredientDOCOSANOL
Label structure11 sections

Indications and 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 and administration

• 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

Storage and handling

• store at 20 o -25 o C (68 o -77 o F) • do not freeze

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docosanol 10%

Purpose

OTC - PURPOSE SECTION

Cold sore/fever blister treatment

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • if you are allergic to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • your cold sore gets worse or the cold sore is not healed within 10 days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • store at 20o-25oC (68o-77oF)
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-709-3539

Additional information

SPL UNCLASSIFIED SECTION

*ABREVA contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

Retain this insert for full product uses, directions and warnings.

If you are not completely satisfied, save receipt and remaining product, and call us at 1-877-709-3539.

Trademarks are owned by or licensed to the GSK group of companies.

Distributed for Avanir Pharmaceuticals by

GSKConsumer Healthcare

Warren, NJ 07059, Made in Germany

©2020 GSK or licensor.

Thank you for puchasing ABREVA. We hope that since ABREVA shortens the healing time of cold sores, it helps you look and feel better faster. Please follow insert directions for proper use and refer to the information below.

You are not alone

An estimated one-in-five Americans is affected by cold sores each year. Most people who experience them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore infection can be easily passed on to others. It is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one.

Getting to the Root of the Problem

A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation.

The Sooner, the Better

A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using ABREVA, the more effective the medicine will be. So for best results, use ABREVA at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

Frequently Asked Questions:

How is ABREVA different from the Over-The-Counter cold sore remedies I have already been using?

Abreva contains 10% docosanol, the only FDA approved non-prescription ingredient that can actually shorten healing time and the duration of symptoms including tingling, pain, itching, and burning. The sooner you start using ABREVA, the sooner you can begin healing your cold sore. No other Over-The-Counter cold sore product heals your cold sore faster.

Who can use ABREVA?

Adults and children 12 years and over can use ABREVA.

How often can I apply ABREVA?

ABREVA should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.

Can I apply cosmetics on top of ABREVA?

Yes, cosmetics such as lipstick may be applied over ABREVA. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying ABREVA.

For More Information:

  1. Call us at 1-877-709-3539

Abreva
DOCOSANOL 10% CREAM
COLD SORE/FEVER BLISTER TREATMENT

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-3476

NDC: 50090-3476-0 2 g in a TUBE

docosanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855205Abreva 10 % Topical CreamPSN5
797534docosanol 10 % Topical CreamPSN5
855205docosanol 100 MG/ML Topical Cream [Abreva]SBD5
797534docosanol 100 MG/ML Topical CreamSCD5
855205Abreva 10 % Topical CreamSY5
797534docosanol 10 % Topical CreamSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3476-02023-01-30C16284748780-1f386c649-edbd-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3476-0ABREVA2 g in 1 TUBECREAM25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3476ABREVA (DOCOSANOL) CREAM [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210417_8b292cc5-c9ec-44ab-8c08-ba153a58d9fd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0200-01GM - Gram0135-02003ef7e703-fc30-449e-a5cd-21670dfd305d12012-07-24
0135-0200-03GM - Gram0135-0200c31659c2-e299-40ca-a41a-5ac16e27948112012-07-24
0135-0200-05GM - Gram0135-020070ef30a4-324f-46d2-8b07-d75741ffaa7512017-07-07
0135-0200-06GM - Gram0135-0200623cfb8d-fa47-471d-a8b5-b07e48c439ab12025-02-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-347650090-3476-0
0135-0200

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020941-001ABREVADOCOSANOL10%CREAM / TOPICALRLD, RS2000-07-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABREVADOCOSANOLHaleon US Holdings LLCc39b38a7-dcdd-4c32-8f35-b565c4d3cec62024-06-20WarningsExact identifier
ndc (product): 0135-0200
d91f4d8f-934f-45b0-805b-2223158023818b292cc5-c9ec-44ab-8c08-ba153a58d9fd2021-04-16WarningsExact identifier
spl id: d91f4d8f-934f-45b0-805b-222315802381
spl set id: 8b292cc5-c9ec-44ab-8c08-ba153a58d9fd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.