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: Family Dollar (FAMILY WELLNESS)
Product type: HUMAN OTC DRUG
SPL set ID: 40297d6b-1096-467b-906c-701959884566
SPL ID: 257bed83-00db-4b7e-98b7-3f7b6fc34266
Version: 5
Effective date: 2025-10-08
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:37:56

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	208754	derived:openfda.application_number
application number		ANDA208754	openfda.application_number
brand name		Docosanol	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		Family Dollar (FAMILY WELLNESS)	openfda.manufacturer_name
ndc	package	55319-922-07	openfda.package_ndc
ndc	product	55319-922	openfda.product_ndc
ndc11	package	55319092207	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		257bed83-00db-4b7e-98b7-3f7b6fc34266	id
spl set id		40297d6b-1096-467b-906c-701959884566	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 shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only

Reported adverse events (FAERS/openFDA)#

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