FDA.reportPublic FDA data

NDC 37205-308-64 - LEADER Azo Tabs Urinary Tract Analgesic

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
37205-308
Requested NDC
37205-308-64
Package NDCs from labels
37205-308-64, 37205-308-01
Manufacturer
Cardinal Health | Reese Pharmaceutical Co
Effective date
2011-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENAZOPYRIDINE HYDROCHLORIDE - Cardinal Health | Reese Pharmaceutical CoCardinal Health | Reese Pharmaceutical Co2011-01-03HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-308-012025-04-11C16284748780-19d75b9d0-d04b-f424-e053-dadaa90a57ceDRUG FACTS
37205-308-012020-01-31C16284748780-19d75b9d0-d04b-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-308-64EA - Each37205-3088da71656-c82c-4555-96f8-05331813664712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17LEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52LEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZLEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9LEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEADER AZO TABS URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1

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
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
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
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.