PHENAZOPYRIDINE 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: PHENAZOPYRIDINE HYDROCHLORIDE
Generic name: PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer: Genus Lifesciences Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 991b3b97-9cea-4c48-90a4-ebff55417d98
SPL ID: af00a22c-46a2-4a41-b37e-cffebedead20
Version: 2
Effective date: 2026-07-14
Source export date: 2026-10-27
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/55ffdfed5c29f1b4aed512886bd3fb7831e157cc4948137779971a558752ed2b/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:07:32

Harmonized routes table
Harmonized routes
ORAL

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		PHENAZOPYRIDINE HYDROCHLORIDE	openfda.brand_name
generic name		PHENAZOPYRIDINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Genus Lifesciences Inc.	openfda.manufacturer_name
ndc	package	64950-551-01	openfda.package_ndc
ndc	package	64950-550-01	openfda.package_ndc
ndc	product	64950-551	openfda.product_ndc
ndc	product	64950-550	openfda.product_ndc
ndc11	package	64950055101	derived:openfda.package_ndc
ndc11	package	64950055001	derived:openfda.package_ndc
rxcui		1094107	openfda.rxcui
rxcui		1094104	openfda.rxcui
spl id		af00a22c-46a2-4a41-b37e-cffebedead20	id
spl set id		991b3b97-9cea-4c48-90a4-ebff55417d98	set_id
unii		0EWG668W17	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 Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section). To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 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.