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: 15d1a6c5-4a61-48f3-b45e-a7e34cbeb294
SPL ID: 3a93fdcf-bd3a-48ed-9821-48947cc2ac2a
Version: 2
Effective date: 2022-10-18
Source export date: 2026-10-30
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/2026-10-30/a900515c00f4d0d29f88cc94ee68daf127f036296f87a6b4a8a3f964cd0433c0/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:48:39

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		P & L Development, LLC	openfda.manufacturer_name
ndc	package	59726-924-07	openfda.package_ndc
ndc	product	59726-924	openfda.product_ndc
ndc11	package	59726092407	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		3a93fdcf-bd3a-48ed-9821-48947cc2ac2a	id
spl set id		15d1a6c5-4a61-48f3-b45e-a7e34cbeb294	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.