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 toll free 1-888-423-0139
†COMPARE TO THE ACTIVE INGREDIENT IN ABREVA®
Cold Sore Treatment
COLD SORE/FEVER BLISTER TREATMENT
DOCOSANOL CREAM, 10%
NET WT 2 g (0.07 oz)
*Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.
†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ITASCA, IL 60143
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0036800496415 | GTIN-13: 0036800496415 EAN-13: 0036800496415 GTIN-12: 036800496415 UPC-A: 036800496415 GTIN storage (14 digits): 00036800496415 | docosanol-10-percent-creamene-1.jpg |
| QR code link | QR Code | docosanol-10-percent-creamene-1.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-818-07 | Cold Sore Fever Blister Treatment | 1 in 1 PACKAGE | CREAM | 1 | 3 | |
| 76162-818-07 | Cold Sore Fever Blister Treatment | 2 g in 1 TUBE | CREAM | 2 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76162-818 | 76162-818-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A212385-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-10-07 | c2088c7a36db… | ||
| 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 | Topco Associates | 73348ce7-5b08-49ad-ba59-6f54887f819b | 2025-12-29 | Warnings | 76162-818-07 76162-818 76162081807 12928119-fbf0-4732-9e4f-b77ab18304eb 73348ce7-5b08-49ad-ba59-6f54887f819b |
Adverse event summaries are temporarily unavailable. Other product information remains available.