Docosanol Cream, 10%

Manufacturer: Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited
Effective date: 2023-12-22
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:05:29

Label at a glance#

ProductDocosanol

Active ingredientDOCOSANOL

Label structure10 sections

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

Dosage and administration

adults and children 12 years or over: • wash hands before and after applying cream • apply to affected area on 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#

PhoneLabel contact1-866-210-9797

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docosanol 10%

Purpose

OTC - PURPOSE SECTION

Cold sore/fever blister treatment

Uses

INDICATIONS & USAGE SECTION

treats cold sores/fever blisters on the face or lips
shortens healing time and duration of symptoms:

• tingling, pain, burning, and/or itching

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years or over:

• wash hands before and after applying cream

• apply to affected area on 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

OTHER SAFETY INFORMATION

store at 20° to 25°C (68° to 77°F)
do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-210-9797 Monday-Friday 9AM-6PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Pack

NDC 62332-682-01

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

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

Made in India.

Pump Pack

NDC 62332-682-03

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

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

Made in India.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
797534	docosanol 10 % Topical Cream	PSN	4
797534	docosanol 100 MG/ML Topical Cream	SCD	4
797534	docosanol 10 % Topical Cream	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62332-682-01	Docosanol	1 in 1 PACKAGE	CREAM	1	4
62332-682-01	Docosanol	2 g in 1 TUBE	CREAM	2	4
62332-682-03	Docosanol	2 g in 1 BOTTLE, PUMP	CREAM	2	4
62332-682-03	Docosanol	1 in 1 PACKAGE	CREAM	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-682	DOCOSANOL CREAM [ALEMBIC PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 4 package rows	20231223_86450000-1810-4739-9801-59beb7c19e67.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Docosanol
BENZYL ALCOHOL
LIGHT MINERAL OIL
PROPYLENE GLYCOL
WATER
SUCROSE DISTEARATE
SUCROSE STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62332-682	62332-682-01, 62332-682-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
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#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Docosanol	DOCOSANOL	Alembic Pharmaceuticals Inc.	86450000-1810-4739-9801-59beb7c19e67	2023-12-22	Warnings	Exact identifier ndc (package): 62332-682-01 ndc (package): 62332-682-03 ndc (product): 62332-682 ndc11 (package): 62332068201 ndc11 (package): 62332068203 spl id: 00ec9cfd-4b08-477f-852d-07c753f21a5c spl set id: 86450000-1810-4739-9801-59beb7c19e67

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.