Docosanol

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Docosanol
Generic name: DOCOSANOL
Manufacturer: Sun Pharmaceutical Industries, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 5079b009-7f34-4d34-8f01-821365f04ca2
SPL ID: 57993b31-36bc-4768-e063-6294a90a9ee0
Version: 11
Effective date: 2026-07-27
Source export date: 2026-10-12
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:13:46

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	214454	derived:openfda.application_number
application number		ANDA214454	openfda.application_number
brand name		Docosanol	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		Sun Pharmaceutical Industries, Inc.	openfda.manufacturer_name
ndc	package	51672-1406-6	openfda.package_ndc
ndc	package	51672-1406-2	openfda.package_ndc
ndc	package	51672-1406-5	openfda.package_ndc
ndc	package	51672-1406-3	openfda.package_ndc
ndc	product	51672-1406	openfda.product_ndc
ndc11	package	51672140606	derived:openfda.package_ndc
ndc11	package	51672140602	derived:openfda.package_ndc
ndc11	package	51672140605	derived:openfda.package_ndc
ndc11	package	51672140603	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		57993b31-36bc-4768-e063-6294a90a9ee0	id
spl set id		5079b009-7f34-4d34-8f01-821365f04ca2	set_id
unii		9G1OE216XY	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 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 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.

Reported adverse events (FAERS/openFDA)#

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