Cystex Max UTI Pain Relief

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: Cystex Max UTI Pain Relief
Generic name: PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer: Clarion Brands, LLC
Product type: HUMAN OTC DRUG
SPL set ID: a4d34c20-62af-4a3c-ad2c-046ba08d1ef6
SPL ID: 485b5018-57f0-90d7-e063-6294a90ae5e2
Version: 4
Effective date: 2026-01-14
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:19:03

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		505G(a)(3)	openfda.application_number
brand name		Cystex Max UTI Pain Relief	openfda.brand_name
generic name		PHENAZOPYRIDINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Clarion Brands, LLC	openfda.manufacturer_name
ndc	package	69693-514-24	openfda.package_ndc
ndc	product	69693-514	openfda.product_ndc
ndc11	package	69693051424	derived:openfda.package_ndc
rxcui		1094147	openfda.rxcui
spl id		485b5018-57f0-90d7-e063-6294a90ae5e2	id
spl set id		a4d34c20-62af-4a3c-ad2c-046ba08d1ef6	set_id
unii		0EWG668W17	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not exceed recommended dosage Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Reported adverse events (FAERS/openFDA)#

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