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 5 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthMart Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCb7735e84-c320-4546-80c9-58c172097fa82024-12-18WarningsExact identifier
rxcui: 1094126
unii: 0EWG668W17
TopCare Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETOPCO ASSOCIATES LLC1662f712-6756-4dcd-bdfa-b4ed28c0d69a2024-12-18WarningsExact identifier
unii: 0EWG668W17
Premier Value Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Consortium, LLCbd7a027f-1175-4f9f-b61d-50bda0feaff22024-12-18WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEBryant Ranch Prepack7367afd6-6bf6-4240-a274-79b7a5de97152024-12-12Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LP6c3adf9f-7179-43b7-8397-4148a9146a2c2024-11-01Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEAmneal Pharmaceuticals LLCb424b50f-990b-4018-a815-0311693cabb32024-10-30Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEA-S Medication Solutions7e0f2ba8-003c-4303-80fd-76f70ddc2c112024-10-14Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Rite Aid Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDERite Aidb0634f37-53c4-47c4-a68e-710c944f213b2024-10-11WarningsExact identifier
unii: 0EWG668W17
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: J2B2A4N98G
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE,Deseret Biologicals, Inc.e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf2024-09-06WarningsExact identifier
unii: J2B2A4N98G
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.b11bdb87-4ebc-3a14-e053-2a95a90a7d732024-07-17WarningsExact identifier
rxcui: 1094126
unii: 0EWG668W17
Phenazopyridine HCLPHENAZOPYRIDINE HCLDirect Rx0e34badf-c886-08c1-e063-6294a90aeefd2024-07-09Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Foster and Thrive Neighbor Pharmacy Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCc1a0f3be-d848-4728-a5e8-c14d63ec0af72024-06-21WarningsExact identifier
rxcui: 1094126
unii: 0EWG668W17
Foster and Thrive Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLC97ea2a3e-c1a0-437d-ac2a-2128e193183b2024-06-21WarningsExact identifier
unii: 0EWG668W17
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: J2B2A4N98G
Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEAdvanced Rx LLCa10464cf-36b2-460f-b31c-2e0edee3e4cf2024-05-01WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LPac155091-ee07-46da-bb25-ff4cd40746102024-05-01Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: J2B2A4N98G
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LP140a40f8-26ec-46ac-a04b-998ea96e8f932024-02-01Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: J2B2A4N98G

Reported adverse events (FAERS/openFDA)#

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