Cystex Max UTI Pain Relief

Product NDC: 69693-514
11-digit product format: 696930514
Labeler code: 69693
Product ID: 69693-514_485b5018-57f0-90d7-e063-6294a90ae5e2
Type: HUMAN OTC DRUG
Nonproprietary name: Phenazopyridine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Clarion Brands, LLC
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-08-02
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 99.5 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Cystex Max UTI Pain Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENAZOPYRIDINE HYDROCHLORIDE	99.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0EWG668W17	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094147	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a4d34c20-62af-4a3c-ad2c-046ba08d1ef6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69693-514-24	Cystex Max UTI Pain Relief	24 in 1 BLISTER PACK	TABLET	24		4
69693-514-24	Cystex Max UTI Pain Relief	1 in 1 CARTON	TABLET	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69693-514	CYSTEX MAX UTI PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CLARION BRANDS, LLC]	1	Current NDC, 2 package rows	20240802_a4d34c20-62af-4a3c-ad2c-046ba08d1ef6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cystex Max UTI Pain Relief	PHENAZOPYRIDINE HYDROCHLORIDE	Clarion Brands, LLC	a4d34c20-62af-4a3c-ad2c-046ba08d1ef6	2026-01-14	Warnings	Exact identifier ndc (product): 69693-514

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0EWG668W17	PHENAZOPYRIDINE HYDROCHLORIDE	136-40-3	PHENAZOPYRIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094147	phenazopyridine HCl 99.5 MG Oral Tablet	PSN	a4d34c20-62af-4a3c-ad2c-046ba08d1ef6	4
1094147	phenazopyridine hydrochloride 99.5 MG Oral Tablet	SCD	a4d34c20-62af-4a3c-ad2c-046ba08d1ef6	4
1094147	phenazopyridine HCl 99.5 MG Oral Tablet	SY	a4d34c20-62af-4a3c-ad2c-046ba08d1ef6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69693-514-24	69693051424	1 BLISTER PACK in 1 CARTON (69693-514-24) / 24 TABLET in 1 BLISTER PACK	1 blister pack	2024-08-02	No	No	Current