FDA.reportPublic FDA data

URO-PAIN

Product NDC
57237-331
11-digit product format
572370331
Labeler code
57237
Product ID
57237-331_87a9fce7-4a16-4d25-84da-ee961c430efa
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-06
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
95 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
URO-PAINPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.f0817ef7-c269-4881-81d9-ffc64b404b7e2023-12-14WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. Stop use and ask doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication. If pregnant or breastfeeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
URO-PAIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE95 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-331-03URO-PAIN30 in 1 BLISTER PACKTABLET301
57237-331-03URO-PAIN1 in 1 CARTONTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-331-03EA - Each57237-3318c4ee716-6356-430b-a61e-71f153382be012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-331URO-PAIN (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 2 package rows20240113_f0817ef7-c269-4881-81d9-ffc64b404b7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSNf0817ef7-c269-4881-81d9-ffc64b404b7e1
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCDf0817ef7-c269-4881-81d9-ffc64b404b7e1
1094126phenazopyridine HCl 95 MG Oral TabletSYf0817ef7-c269-4881-81d9-ffc64b404b7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-331-03572370331031 BLISTER PACK in 1 CARTON (57237-331-03) / 30 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent