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
- Rugby Laboratories | Alembic Pharmaceuticals Limited | Contract Packaging Resources, Inc.
- Effective date
- 2024-05-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:54
Label at a glance#
ProductDOCOSANOL
Active ingredientDOCOSANOL
Label structure10 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#
Websitewww.majorpharmaceuticals.com
www.majorpharmaceuticals.com
www.majorpharmaceuticals.comLabel 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 1-866-210-9797 Monday-Friday 9AM-6PM EST
PRINCIPAL DISPLAY PANEL
TUBE PACK
NDC 0536-1427-04
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®**
Cold Sore/Fever Blister Treatment
Non-prescription Medicine to Shorten Healing Time*
Cold Sore Treatment
For Topical Use Only
NET WT 2g (0.07 oz)
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
*Contains the only non-prescription cold sore 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:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
Code No.: GUJ/DRUGS/G/25/2216
Made in India
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0536-1427-04 | DOCOSANOL | 2 g in 1 TUBE | CREAM | 2 | 1 | |
| 0536-1427-04 | DOCOSANOL | 1 in 1 PACKAGE | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1427-04 | GM - Gram | 0536-1427 | e88e5c7b-98eb-48fe-af32-4857aff780b6 | 1 | 2025-03-04 |
Products#
Every source-derived product name is available through these pages.
- DOCOSANOL
- BENZYL ALCOHOL
- LIGHT MINERAL OIL
- PROPYLENE GLYCOL
- WATER
- SUCROSE DISTEARATE
- SUCROSE STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0536-1427 | 0536-1427-04 |
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 | 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 |
|---|---|---|---|---|---|---|---|
| A215839-001 | DOCOSANOL | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 5c6f7cd8ea54… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215839-001 | DOCOSANOL | 10% | CREAM / TOPICAL | 2022-05-03 | 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 | Rugby Laboratories | 6f8d6375-8188-42e9-a048-e8a554122ff3 | 2024-05-23 | Warnings | 0536-1427-04 0536-1427 00536142704 9b89030f-1b9a-4519-96d0-5e40b9e1debd 6f8d6375-8188-42e9-a048-e8a554122ff3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.