FDA.reportPublic FDA data

URO-PAIN

Product NDC
57237-330
11-digit product format
572370330
Labeler code
57237
Product ID
57237-330_033f49f6-f96a-4c44-9c80-fc5d581c3af1
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
99.5 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
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 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
1094147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8e51a62-366c-4533-a5a4-7f996f6f6bd0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-330-21URO-PAINMaximum Strength12 in 1 BLISTER PACKTABLET121
57237-330-21URO-PAINMaximum Strength1 in 1 CARTONTABLET11
57237-330-42URO-PAINMaximum Strength1 in 1 CARTONTABLET11
57237-330-42URO-PAINMaximum Strength24 in 1 BLISTER PACKTABLET241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-330-21EA - Each57237-3309c1c8ce5-c80b-4e90-b0df-24b1b2cd09a312024-03-12
57237-330-42EA - Each57237-330e2100105-4e0c-42ec-a205-c5305dca01d012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-330URO-PAIN MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20240113_a8e51a62-366c-4533-a5a4-7f996f6f6bd0.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-PAIN Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.a8e51a62-366c-4533-a5a4-7f996f6f6bd02023-12-14WarningsExact identifier
ndc (product): 57237-330

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSNa8e51a62-366c-4533-a5a4-7f996f6f6bd01
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCDa8e51a62-366c-4533-a5a4-7f996f6f6bd01
1094147phenazopyridine HCl 99.5 MG Oral TabletSYa8e51a62-366c-4533-a5a4-7f996f6f6bd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-330-21572370330211 BLISTER PACK in 1 CARTON (57237-330-21) / 12 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent
57237-330-42572370330421 BLISTER PACK in 1 CARTON (57237-330-42) / 24 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent