FDA.reportPublic FDA data

NDC 70000-0243-01 - Leader Urinary Pain Relief

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70000-0243
Requested NDC
70000-0243-01
Package NDCs from labels
70000-0243-1, 70000-0243-01
Manufacturer
Cardinal Health | Reese Pharmaceutical Co
Effective date
2024-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Urinary Pain Relief - Cardinal Health | Reese Pharmaceutical CoCardinal Health | Reese Pharmaceutical Co2024-12-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0243-1Leader Urinary Pain Relief30 in 1 BLISTER PACKTABLET305
70000-0243-1Leader Urinary Pain Relief1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0243LEADER URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]5Current NDC, Legacy NDC, 2 package rows20241220_d1d1d4de-ab20-40fa-a6cf-53d805c7ecb3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0243-1EA - Each70000-02432d1fee72-a2ff-440f-b4a6-be0fc3d922d512017-12-14

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 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.49baf6e5-133a-4e1a-9740-506673d27caf2026-08-21Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.c0e5d32e-075f-4c76-8332-a06560001efe2026-08-14Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.132cc592-6b03-4b75-bf39-df476fb9dc812026-08-14Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc96308f8c-66e7-486a-a5c0-ee9a133ad0512026-08-14Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ce702be2-eec2-4346-965e-f1f6ba342fc92026-08-14Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.f6829698-b12e-484d-a322-d2f68586e6372026-08-07Adverse reactionsExact identifier
unii: 0EWG668W17
Gencare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEPioneer Life Sciences, LLC6bbf15b4-2954-40ff-8460-1ef0ed8906542026-08-03WarningsExact identifier
unii: 0EWG668W17
Nuvicare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDENUVICARE LLC5fe4e4dc-f1c4-4617-b6a6-6ea16a63abfe2026-08-03WarningsExact identifier
unii: 0EWG668W17
Cystex Max Strength UTI Pain ReliefCYSTEX MAX STRENGTH UTI PAIN RELIEFClarion Brands LLC57482f71-80d3-b20d-e063-6394a90a0cf42026-07-27WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.6eb59b69-4ad0-47b1-bd3c-1d04d0852ec52026-07-27Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.56ad921f-0b6e-aa2b-e063-6394a90aec6b2026-07-15Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDEGenus Lifesciences Inc.991b3b97-9cea-4c48-90a4-ebff55417d982026-07-14Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.7e131f69-d259-404d-a859-0497f5cbe8562026-06-24Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.548edf26-c81e-f982-e063-6394a90af9da2026-06-18Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.82dc87bb-ba27-4b86-9bc9-18492975ac9f2026-06-10Adverse reactionsExact identifier
unii: 0EWG668W17
Preferred Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0fa8638c-e3e0-4bbf-9101-842e5d8736d62026-06-04WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEGPT Pharmaceuticals Private Limited7332cbf1-ceda-415b-b4d5-a100057a7d012026-05-12WarningsExact identifier
unii: 0EWG668W17
UTI PAIN RELIEFPHENAZOPYRIDINE HYDROCHLORIDECadence Health7fa8e314-025c-46c2-b97a-91c4f385e5652026-04-06WarningsExact identifier
unii: 0EWG668W17
Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEYYBA CORPf2d9f6aa-081e-4723-9417-5191b31d29522026-04-01WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HCLPHENAZOPYRIDINE HCLDirect_Rx10cd6fad-1923-ad00-e063-6394a90a95542026-03-05Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.