Cold Sore Fever Blister 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 Fever Blister Treatment
Generic name: DOCOSANOL
Manufacturer: Topco Associates
Product type: HUMAN OTC DRUG
SPL set ID: 65351744-0438-4416-ae1f-9169fc21d813
SPL ID: a91e107a-2f8e-4eb3-b1be-e93009f2dba1
Version: 3
Effective date: 2025-09-11
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:16:36

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 Fever Blister Treatment	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		Topco Associates	openfda.manufacturer_name
ndc	package	76162-900-07	openfda.package_ndc
ndc	product	76162-900	openfda.product_ndc
ndc11	package	76162090007	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		a91e107a-2f8e-4eb3-b1be-e93009f2dba1	id
spl set id		65351744-0438-4416-ae1f-9169fc21d813	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.