Pyridium

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: Pyridium
Generic name: PHENAZOPYRIDINE
Manufacturer: Amneal Pharmaceuticals LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 165d01d4-a9f7-2293-e054-00144ff8d46c
SPL ID: 660bbb22-af0c-4025-949d-4681cd4147e1
Version: 15
Effective date: 2023-12-16
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 19:38:11

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Pyridium	openfda.brand_name
generic name		PHENAZOPYRIDINE	openfda.generic_name
manufacturer name		Amneal Pharmaceuticals LLC	openfda.manufacturer_name
ndc	package	60846-502-01	openfda.package_ndc
ndc	package	60846-501-01	openfda.package_ndc
ndc	product	60846-501	openfda.product_ndc
ndc	product	60846-502	openfda.product_ndc
ndc11	package	60846050201	derived:openfda.package_ndc
ndc11	package	60846050101	derived:openfda.package_ndc
rxcui		1094109	openfda.rxcui
rxcui		1094107	openfda.rxcui
rxcui		1094122	openfda.rxcui
rxcui		1094104	openfda.rxcui
spl id		660bbb22-af0c-4025-949d-4681cd4147e1	id
spl set id		165d01d4-a9f7-2293-e054-00144ff8d46c	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).

Reported adverse events (FAERS/openFDA)#

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