ABREVA

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: ABREVA
Generic name: DOCOSANOL
Manufacturer: Haleon US Holdings LLC
Product type: HUMAN OTC DRUG
SPL set ID: bf02c8c5-af60-41f1-a202-38a97491a720
SPL ID: 1b529b4c-e36d-5070-e063-6294a90ac5c8
Version: 5
Effective date: 2024-06-20
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:02

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 · 15 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		ABREVA	openfda.brand_name
generic name		DOCOSANOL	openfda.generic_name
manufacturer name		Haleon US Holdings LLC	openfda.manufacturer_name
ndc	package	0135-0300-02	openfda.package_ndc
ndc	package	0135-0300-01	openfda.package_ndc
ndc	product	0135-0300	openfda.product_ndc
ndc11	package	00135030001	derived:openfda.package_ndc
ndc11	package	00135030002	derived:openfda.package_ndc
rxcui		797534	openfda.rxcui
rxcui		855205	openfda.rxcui
spl id		1b529b4c-e36d-5070-e063-6294a90ac5c8	id
spl set id		bf02c8c5-af60-41f1-a202-38a97491a720	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 Do not use if you are allergic to any ingredient in this product When using this product apply only to affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread infection. Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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