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: P & L Development, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 53cd18dc-bece-473e-a116-df6c88fe6fe7
SPL ID: 0ebd37a8-19cc-4ac3-b73a-11ad38a0e2e2
Version: 3
Effective date: 2025-12-29
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:53

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	212385	derived:openfda.application_number
application number		ANDA212385	openfda.application_number
brand name		Cold Sore Treatment	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		P & L Development, LLC	openfda.manufacturer_name
ndc	package	59726-112-14	openfda.package_ndc
ndc	package	59726-112-07	openfda.package_ndc
ndc	product	59726-112	openfda.product_ndc
ndc11	package	59726011207	derived:openfda.package_ndc
ndc11	package	59726011214	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		0ebd37a8-19cc-4ac3-b73a-11ad38a0e2e2	id
spl set id		53cd18dc-bece-473e-a116-df6c88fe6fe7	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.