Cold Sore Fever Blister

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
Generic name: DOCOSANOL
Manufacturer: H E B
Product type: HUMAN OTC DRUG
SPL set ID: 71b2bb18-4a48-42c2-b03a-dccf581a0d97
SPL ID: 94d4fe1d-4c25-4fc9-b6f4-b2f6436a0cbf
Version: 5
Effective date: 2025-12-29
Source export date: 2026-10-30
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:58:57

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 Fever Blister	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		H E B	openfda.manufacturer_name
ndc	package	37808-661-07	openfda.package_ndc
ndc	package	37808-661-14	openfda.package_ndc
ndc	product	37808-661	openfda.product_ndc
ndc11	package	37808066114	derived:openfda.package_ndc
ndc11	package	37808066107	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
spl id		94d4fe1d-4c25-4fc9-b6f4-b2f6436a0cbf	id
spl set id		71b2bb18-4a48-42c2-b03a-dccf581a0d97	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 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.