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: Winder Laboratories, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0a190e86-4074-4822-888e-4952281712ea
SPL ID: e0537551-5536-d23c-e053-2995a90af439
Version: 6
Effective date: 2022-05-31
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:23:55

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 HYDROCHLORIDE	openfda.generic_name
manufacturer name		Winder Laboratories, LLC	openfda.manufacturer_name
ndc	package	75826-114-10	openfda.package_ndc
ndc	package	75826-115-10	openfda.package_ndc
ndc	product	75826-114	openfda.product_ndc
ndc	product	75826-115	openfda.product_ndc
ndc11	package	75826011410	derived:openfda.package_ndc
ndc11	package	75826011510	derived:openfda.package_ndc
rxcui		1094107	openfda.rxcui
rxcui		1094104	openfda.rxcui
spl id		e0537551-5536-d23c-e053-2995a90af439	id
spl set id		0a190e86-4074-4822-888e-4952281712ea	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.