Docosanol Cream 10%

Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date: 2026-10-16
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: daily-update
Hydrated at: 2026-10-20 03:02:23

Label at a glance#

ProductDocosanol

Active ingredientDOCOSANOL

Label structure12 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

Storage and handling

TAMPER-EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE store between 20° to 25°C (68° to 77°F) do not freeze

Contacts and useful links#

PhoneLabel contact1-866-923-4914

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

apply only to 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 infection.

Stop use and ask a doctor if

OTC - STOP USE SECTION

your cold sore gets worse or the cold sore is not healed within 10 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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

STORAGE AND HANDLING SECTION

TAMPER-EVIDENT:DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE
store between 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 and sucrose stearate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Ohm Laboratories Inc.
New Brunswick, NJ 08901

Made in Canada

PRINCIPAL DISPLAY PANEL - 2 g Tube Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-1406-3

Compare to the active
ingredient in Abreva ^®*

Docosanol
Cream 10%

Cold Sore
Fever Blister
Treatment

Cold Sore
Treatment

Only FDA
Approved
Medicine to
Shorten
Healing Time ^✝

For Topical Use Only

Net Wt. 2 g (0.07 oz)

carton-01

PRINCIPAL DISPLAY PANEL- 2 g Tube Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister Card

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0351672140632	GTIN-13: 0351672140632 EAN-13: 0351672140632 GTIN-12: 351672140632 UPC-A: 351672140632 GTIN storage (14 digits): 00351672140632	Ohm Docosanol Cream 2g Single Pack.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1406-2	GM - Gram	51672-1406	33f05b37-003e-4353-8d89-ec5296722a08	1	2025-09-12
51672-1406-3	GM - Gram	51672-1406	e8f1fce7-3a63-417a-ad63-ae507d92dd1e	1	2025-09-12

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 STEARATE
SUCROSE DISTEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-1406	51672-1406-3, 51672-1406-2

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 STEARATE	274KW0O50M	IACT
SUCROSE DISTEARATE	33X4X4B90S	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
11	2026-07-27	daily-update	2026-09-08 02:01:35
10	2026-06-19	monthly-update	2026-07-17 21:34:49
9	2025-12-22	full-release	2026-06-01 01:27:52

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 44.

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
A214454-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2023-10-26

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
2026-10-15 13:18:30	2026-09	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214454-001	DOCOSANOL	10%	CREAM / TOPICAL	2023-10-26	`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	Sun Pharmaceutical Industries, Inc.	5079b009-7f34-4d34-8f01-821365f04ca2	2026-07-27	Warnings	Exact identifier ndc (package): 51672-1406-2 ndc (package): 51672-1406-3 ndc (product): 51672-1406 ndc11 (package): 51672140602 ndc11 (package): 51672140603 spl set id: 5079b009-7f34-4d34-8f01-821365f04ca2

Reported adverse events (FAERS/openFDA)#

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