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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094126Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0817ef7-c269-4881-81d9-ffc64b404b7eAvailable on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
URO-PAINPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.f0817ef7-c269-4881-81d9-ffc64b404b7e2023-12-14WarningsExact identifier
ndc (product): 57237-331

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