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
• treats cold sores/fever blisters on the face or lips • shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching
• 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
• store at 20 o -25 o C (68 o -77 o F) • do not freeze
Docosanol 10%
Cold sore/fever blister treatment
Allergy alert
This product may cause a severe allergic reaction. Symptoms
may include:
If an allergic reaction occurs, stop use and seek medical help right away.
For external use only
If swallowed, get medical help or contact a Poison Control Center right away.
benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate
Call toll-free 1-877-709-3539
*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:
Abreva
DOCOSANOL 10% CREAM
COLD SORE/FEVER BLISTER TREATMENT
Product: 50090-3476
NDC: 50090-3476-0 2 g in a TUBE
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 855205 | Abreva 10 % Topical Cream | PSN | 5 |
| 797534 | docosanol 10 % Topical Cream | PSN | 5 |
| 855205 | docosanol 100 MG/ML Topical Cream [Abreva] | SBD | 5 |
| 797534 | docosanol 100 MG/ML Topical Cream | SCD | 5 |
| 855205 | Abreva 10 % Topical Cream | SY | 5 |
| 797534 | docosanol 10 % Topical Cream | SY | 5 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3476-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-edbd-0266-e053-dadaa90a7c1a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3476-0 | ABREVA | 2 g in 1 TUBE | CREAM | 2 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3476 | ABREVA (DOCOSANOL) CREAM [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 1 package rows | 20210417_8b292cc5-c9ec-44ab-8c08-ba153a58d9fd.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0200-01 | GM - Gram | 0135-0200 | 3ef7e703-fc30-449e-a5cd-21670dfd305d | 1 | 2012-07-24 |
| 0135-0200-03 | GM - Gram | 0135-0200 | c31659c2-e299-40ca-a41a-5ac16e279481 | 1 | 2012-07-24 |
| 0135-0200-05 | GM - Gram | 0135-0200 | 70ef30a4-324f-46d2-8b07-d75741ffaa75 | 1 | 2017-07-07 |
| 0135-0200-06 | GM - Gram | 0135-0200 | 623cfb8d-fa47-471d-a8b5-b07e48c439ab | 1 | 2025-02-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-3476 | 50090-3476-0 |
| 0135-0200 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCOSANOL | 9G1OE216XY | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCROSE DISTEARATE | 33X4X4B90S | IACT |
| SUCROSE STEARATE | 274KW0O50M | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020941-001 | ABREVA | DOCOSANOL | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020941-001 | ABREVA | 10% | CREAM / TOPICAL | RLD, RS | 2000-07-25 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ABREVA | DOCOSANOL | Haleon US Holdings LLC | c39b38a7-dcdd-4c32-8f35-b565c4d3cec6 | 2024-06-20 | Warnings | 0135-0200 |
| d91f4d8f-934f-45b0-805b-222315802381 | 8b292cc5-c9ec-44ab-8c08-ba153a58d9fd | 2021-04-16 | Warnings | d91f4d8f-934f-45b0-805b-222315802381 8b292cc5-c9ec-44ab-8c08-ba153a58d9fd |
Adverse event summaries are temporarily unavailable. Other product information remains available.