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: Northwind Health Company, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: f2f3e29f-9553-f7c3-e053-2995a90aff36
SPL ID: 48ff21cd-c20e-07ba-e063-6394a90aa36a
Version: 2
Effective date: 2026-01-01
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:25:51

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		Northwind Health Company, LLC	openfda.manufacturer_name
ndc	package	51655-424-27	openfda.package_ndc
ndc	package	51655-424-87	openfda.package_ndc
ndc	package	51655-424-53	openfda.package_ndc
ndc	product	51655-424	openfda.product_ndc
ndc11	package	51655042427	derived:openfda.package_ndc
ndc11	package	51655042453	derived:openfda.package_ndc
ndc11	package	51655042487	derived:openfda.package_ndc
rxcui		1094104	openfda.rxcui
spl id		48ff21cd-c20e-07ba-e063-6394a90aa36a	id
spl set id		f2f3e29f-9553-f7c3-e053-2995a90aff36	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 Amneal Pharmaceuticals at 1-877-835-5472 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.