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: Proficient Rx LP
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: b7a5da89-dc52-4b61-8a54-262d0826c635
SPL ID: b7a5da89-dc52-4b61-8a54-262d0826c635
Version: 1
Effective date: 2025-02-01
Source export date: 2026-10-30
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:39:36

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 · 12 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		Proficient Rx LP	openfda.manufacturer_name
ndc	package	82804-192-12	openfda.package_ndc
ndc	package	82804-192-18	openfda.package_ndc
ndc	product	82804-192	openfda.product_ndc
ndc11	package	82804019212	derived:openfda.package_ndc
ndc11	package	82804019218	derived:openfda.package_ndc
rxcui		1094107	openfda.rxcui
spl id		b7a5da89-dc52-4b61-8a54-262d0826c635	id
spl set id		b7a5da89-dc52-4b61-8a54-262d0826c635	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 Error! Hyperlink reference not valid. 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.