PAPAVERINE HYDROCHLORIDE

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: PAPAVERINE HYDROCHLORIDE
Generic name: PAPAVERINE HYDROCHLORIDE
Manufacturer: BPI Labs LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 6f16f2ed-8e1c-4c6f-bd1d-846e02b1be97
SPL ID: afdd82fd-269d-4d51-b3f1-515ce7ead96d
Version: 9
Effective date: 2025-12-26
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:54:59

Harmonized routes table
Harmonized routes
INTRAMUSCULAR, INTRAVENOUS, PARENTERAL

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
brand name		PAPAVERINE HYDROCHLORIDE	openfda.brand_name
generic name		PAPAVERINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		BPI Labs LLC	openfda.manufacturer_name
ndc	package	54288-142-25	openfda.package_ndc
ndc	package	54288-142-10	openfda.package_ndc
ndc	package	54288-142-01	openfda.package_ndc
ndc	product	54288-142	openfda.product_ndc
ndc11	package	54288014210	derived:openfda.package_ndc
ndc11	package	54288014225	derived:openfda.package_ndc
ndc11	package	54288014201	derived:openfda.package_ndc
rxcui		1789947	openfda.rxcui
spl id		afdd82fd-269d-4d51-b3f1-515ce7ead96d	id
spl set id		6f16f2ed-8e1c-4c6f-bd1d-846e02b1be97	set_id
unii		23473EC6BQ	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following side effects have been reported: general discomfort, nausea, abdominal discomfort, anorexia, constipation or diarrhea, skin rash, malaise, vertigo, headache, intensive flushing of the face, perspiration, increase in the depth of respiration, increase in heart rate, a slight rise in blood pressure, and excessive sedation. Hepatitis, probably related to an immune mechanism, has been reported infrequently. Rarely, this has progressed to cirrhosis. To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at (727) 471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Reported adverse events (FAERS/openFDA)#

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