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 Healthcare Holdings (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.
Manufactured for FSA Store Inc.
5473 BLAIR ROAD
SUITE 100
PMB 24308
DALLAS, TX 75231
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81522-112-07 | Cold Sore Fever Blister Treatment | 2 g in 1 TUBE | CREAM | 2 | 4 | |
| 81522-112-07 | Cold Sore Fever Blister Treatment | 1 in 1 PACKAGE | CREAM | 1 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 81522-112 | 81522-112-07 |
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 |
|---|---|---|---|---|---|---|
| Cold Sore Fever Blister Treatment | DOCOSANOL | FSA Store Inc. (Caring Mills) | fe67f56e-4c35-40cb-8a75-174a873f2900 | 2025-12-29 | Warnings | 81522-112-07 81522-112 81522011207 788e64c2-c330-4488-aa87-35fdd7fed014 fe67f56e-4c35-40cb-8a75-174a873f2900 |
Adverse event summaries are temporarily unavailable. Other product information remains available.