ABREVA

Manufacturer
Haleon US Holdings LLC
Effective date
2024-06-20
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 00:13:55

Label at a glance#

ProductABREVA
Active ingredientDOCOSANOL
Label structure10 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 20 o-25 oC (68 o-77 oF)
  • 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.

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:

Call us at 1-877-709-3539

Abreva
DOCOSANOL 10% CREAM
COLD SORE/FEVER BLISTER TREATMENT

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

abreva

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Cold Sore Treatment

Beauty Unaltered

NET WT

2g (0.07 oz)

1000771

Abreva 2g tube print card
Abreva 2g tube print card

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855205Abreva 10 % Topical CreamPSN16
797534docosanol 10 % Topical CreamPSN16
855205docosanol 100 MG/ML Topical Cream [Abreva]SBD16
797534docosanol 100 MG/ML Topical CreamSCD16
855205Abreva 10 % Topical CreamSY16
797534docosanol 10 % Topical CreamSY16

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0200-01ABREVA2 g in 1 TUBECREAM216
0135-0200-03ABREVA2 g in 1 BOTTLE, PUMPCREAM216
0135-0200-04ABREVA2 g in 1 TUBECREAM216
0135-0200-04ABREVA2 in 1 PACKAGECREAM216
0135-0200-05ABREVA2 g in 1 TUBECREAM216
0135-0200-05ABREVA2 in 1 PACKAGECREAM216
0135-0200-06ABREVA2 g in 1 BOTTLE, PUMPCREAM216
0135-0200-06ABREVA3 in 1 PACKAGECREAM316

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0200ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC]16Current NDC, Legacy NDC, 8 package rows20240621_c39b38a7-dcdd-4c32-8f35-b565c4d3cec6.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCOSANOLACTIVE INGREDIENT9G1OE216XY6
DOCOSANOLACTIVE MOIETY9G1OE216XY6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
SUCROSE DISTEARATEINACTIVE INGREDIENT33X4X4B90S6
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50M6
WATERINACTIVE INGREDIENT059QF0KO0R6

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
0135-02000135-0200-01, 0135-0200-03, 0135-0200-04, 0135-0200-05, 0135-0200-06

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE DISTEARATESUCROSE DISTEARATE (HLB 5)33X4X4B90SCREAM / TOPICAL25 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE DISTEARATESUCROSE DISTEARATE (HLB 5)33X4X4B90SCREAM / TOPICAL25 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE DISTEARATESUCROSE DISTEARATE (HLB 5)33X4X4B90SCREAM / TOPICAL25 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE DISTEARATESUCROSE DISTEARATE (HLB 5)33X4X4B90SCREAM / TOPICAL25 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE DISTEARATESUCROSE DISTEARATE (HLB 5)33X4X4B90SCREAM / TOPICAL25 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE DISTEARATESUCROSE DISTEARATE (HLB 5)33X4X4B90SCREAM / TOPICAL25 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSE STEARATESUCROSE STEARATE274KW0O50MCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-25c2088c7a36db…
2026-09-14 22:38:342026-08N020941-001ABREVA10%CREAM / TOPICALRLD, RS2000-07-2584e616aacf4f…
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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABREVADOCOSANOLHaleon US Holdings LLCc39b38a7-dcdd-4c32-8f35-b565c4d3cec62024-06-20WarningsExact identifier
ndc (package): 0135-0200-03
ndc (package): 0135-0200-04
ndc (package): 0135-0200-01
ndc (package): 0135-0200-06
ndc (package): 0135-0200-05
ndc (product): 0135-0200
ndc11 (package): 00135020005
ndc11 (package): 00135020004
ndc11 (package): 00135020003
ndc11 (package): 00135020001
ndc11 (package): 00135020006
spl id: 1b525ee7-41df-5a73-e063-6294a90a0b86
spl set id: c39b38a7-dcdd-4c32-8f35-b565c4d3cec6

Reported adverse events (FAERS/openFDA)#

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