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 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
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 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredient in Abreva®††
Docosanol Cream, 10%
COLD SORE / FEVER BLISTER TREATMENT
NET WT g (oz)
††This product is not manufactured or distributed by GlaxoSmithKline Consumer HealthcareHoldings (US) LLC, distributor of Abreva®.
*Docosanol Cream, 10% 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
DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-8980-07 | Docosanol | 2 g in 1 TUBE | CREAM | 2 | 4 | |
| 0363-8980-07 | Docosanol | 1 in 1 PACKAGE | CREAM | 1 | 4 | |
| 0363-8980-14 | Docosanol | 2 g in 1 TUBE | CREAM | 2 | 4 | |
| 0363-8980-14 | Docosanol | 2 in 1 PACKAGE | CREAM | 2 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-8980 | 0363-8980-14, 0363-8980-07 |
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 (HLB 5) | 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 |
|---|---|---|---|---|---|---|---|
| A212385-001 | DOCOSANOL | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 |
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 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | f41ea6bd6efb… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Docosanol | DOCOSANOL | Walgreens | 1500df4d-0c69-4590-a67f-d11edcccd90c | 2025-12-29 | Warnings | 0363-8980-07 0363-8980-14 0363-8980 00363898007 00363898014 b08100e8-c54f-4124-85d3-e078602c868f 1500df4d-0c69-4590-a67f-d11edcccd90c |
Adverse event summaries are temporarily unavailable. Other product information remains available.