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
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094147

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-514-24Cystex Max UTI Pain Relief24 in 1 BLISTER PACKTABLET244
69693-514-24Cystex Max UTI Pain Relief1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69693-514CYSTEX MAX UTI PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CLARION BRANDS, LLC]1Current NDC, 2 package rows20240802_a4d34c20-62af-4a3c-ad2c-046ba08d1ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSNa4d34c20-62af-4a3c-ad2c-046ba08d1ef64
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCDa4d34c20-62af-4a3c-ad2c-046ba08d1ef64
1094147phenazopyridine HCl 99.5 MG Oral TabletSYa4d34c20-62af-4a3c-ad2c-046ba08d1ef64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69693-514-24696930514241 BLISTER PACK in 1 CARTON (69693-514-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2024-08-02NoNoCurrent