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: REMEDYREPACK INC.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 7e131f69-d259-404d-a859-0497f5cbe856
SPL ID: 55019fa1-bdb4-d578-e063-6294a90aa15d
Version: 19
Effective date: 2026-06-24
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:07:02

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		Phenazopyridine Hydrochloride	openfda.brand_name
generic name		PHENAZOPYRIDINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		REMEDYREPACK INC.	openfda.manufacturer_name
ndc	package	70518-0218-2	openfda.package_ndc
ndc	package	70518-0218-3	openfda.package_ndc
ndc	package	70518-0218-0	openfda.package_ndc
ndc	package	70518-0218-1	openfda.package_ndc
ndc	product	70518-0218	openfda.product_ndc
ndc11	package	70518021803	derived:openfda.package_ndc
ndc11	package	70518021800	derived:openfda.package_ndc
ndc11	package	70518021801	derived:openfda.package_ndc
ndc11	package	70518021802	derived:openfda.package_ndc
rxcui		1094107	openfda.rxcui
spl id		55019fa1-bdb4-d578-e063-6294a90aa15d	id
spl set id		7e131f69-d259-404d-a859-0497f5cbe856	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.