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
Docosanol Cream, 10%
- Manufacturer
- AAFES/Your Military Exchanges
- Effective date
- 2025-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:56:46
Label at a glance#
ProductDocosanol
Active ingredientDOCOSANOL
Label structure14 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Docosanol 10%
Purpose
Cold sore/fever blister treatment
Uses
- treats cold sores/fever blisters on the face or lips
- shortens healing time and duration of symptoms:
• tingling, pain, burning, and/or itching
Warnings
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
- if you are allergic to any ingredient in this product
When using this product
- apply only to the 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 the infection.
Stop use and ask a doctor if
- your cold sore gets worse or the cold sore is not healed within 10 days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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
Other information
- store at 20° to 25°C (68° to 77°F)
- do not freeze
Inactive ingredients
benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate
Questions or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal display panel
†Compare to active ingredient in Abreva®
Docosanol Cream, 10%
Cold sore/fever blister treatment
- Only FDA approved medicine to shorten healing time.*
- Cold sore treatment
NET WT 2g (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.
Manufactured for Your Military Exchanges
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
Package label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55301-112-07 | Docosanol | 1 in 1 PACKAGE | CREAM | 1 | 3 | |
| 55301-112-07 | Docosanol | 2 g in 1 TUBE | CREAM | 2 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Docosanol
- BENZYL ALCOHOL
- LIGHT MINERAL OIL
- PROPYLENE GLYCOL
- WATER
- SUCROSE DISTEARATE (HLB 5)
- SUCROSE STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55301-112 | 55301-112-07 |
Ingredients#
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 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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 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.
| 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 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Docosanol | DOCOSANOL | AAFES/Your Military Exchanges | 11272b21-295d-49b3-83bf-5f71899340c5 | 2025-03-07 | Warnings | 55301-112-07 55301-112 55301011207 e3e1a27f-ca0b-4378-bdd9-b7af32a5d357 11272b21-295d-49b3-83bf-5f71899340c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.