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

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-PAIN Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.a8e51a62-366c-4533-a5a4-7f996f6f6bd02023-12-14WarningsExact 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
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

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
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

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