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
Manufacturer: VERITYRX, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 427b6ffb-3ff1-932f-e063-6394a90ae8b9
SPL ID: 427b7010-0678-8eb8-e063-6394a90a7eed
Version: 1
Effective date: 2025-10-31
Source export date: 2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:46:28

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	openfda.generic_name
manufacturer name		VERITYRX, LLC	openfda.manufacturer_name
ndc	package	83939-0021-1	openfda.package_ndc
ndc	package	83939-0021-3	openfda.package_ndc
ndc	package	83939-0021-2	openfda.package_ndc
ndc	product	83939-0021	openfda.product_ndc
ndc11	package	83939002101	derived:openfda.package_ndc
ndc11	package	83939002103	derived:openfda.package_ndc
ndc11	package	83939002102	derived:openfda.package_ndc
rxcui		1094104	openfda.rxcui
spl id		427b7010-0678-8eb8-e063-6394a90a7eed	id
spl set id		427b6ffb-3ff1-932f-e063-6394a90ae8b9	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 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.