Cold Sore Treatment

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: Cold Sore Treatment
Generic name: DOCOSANOL
Manufacturer: FSA Store Inc. (Caring Mills)
Product type: HUMAN OTC DRUG
SPL set ID: a46e4d60-e84b-44a9-9d54-4861dbe91c59
SPL ID: 7f6cfb0e-6357-4328-8fb3-25e99a0f9e85
Version: 2
Effective date: 2022-12-01
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:35

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		Cold Sore Treatment	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		FSA Store Inc. (Caring Mills)	openfda.manufacturer_name
ndc	package	81522-922-07	openfda.package_ndc
ndc	product	81522-922	openfda.product_ndc
ndc11	package	81522092207	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		7f6cfb0e-6357-4328-8fb3-25e99a0f9e85	id
spl set id		a46e4d60-e84b-44a9-9d54-4861dbe91c59	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 cause: 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

Reported adverse events (FAERS/openFDA)#

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