FDA.reportPublic FDA data

NDC 37205-630-53 - LEADER MAXIMUM STRENGHT 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
37205-630
Requested NDC
37205-630-53
Package NDCs from labels
37205-630-53, 37205-630-01
Manufacturer
Cardinal Health | Reese Pharmaceutical Co
Effective date
2020-04-20
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 Co2020-04-20HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEADER MAXIMUM STRENGHT URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF (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 2 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZOURINARY PAIN RELIEFi-Health, Inc.3d0298b7-eaec-488b-9cab-19af4614ff532026-01-05WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINENorthwind Health Company, LLCf2f3e29f-9553-f7c3-e053-2995a90aff362026-01-01Adverse reactionsExact identifier
unii: 0EWG668W17
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: J2B2A4N98G
Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETARGET CORPORATIONe6e27e7f-d04c-5a49-e053-2a95a90a776a2025-12-30WarningsExact identifier
unii: 0EWG668W17
Vexia Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEReese Pharmaceutical Co5fbc47d2-cecd-4187-9bcc-51b1d0b7695d2025-12-29WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINENorthwind Health Company, LLCf29f2ed6-6fd1-fd65-e053-2a95a90aedc42025-12-26Adverse reactionsExact identifier
unii: 0EWG668W17
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDEChartwell RX, LLC9ed3cf8c-e1c1-4290-b094-25ac6f7a9a562025-12-11Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEA-S Medication Solutionsd514fd31-feeb-4371-9b28-eec9834a70032025-12-10Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEA-S Medication Solutionscd78a132-037c-412a-9c56-e38367e05c922025-12-10Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Quality Choice Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Marketing Association45e0cc2f-4a25-40ef-86ed-d1212815d7512025-12-02WarningsExact identifier
unii: 0EWG668W17
Quality Choice Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Marketing Association3cee4fea-f1ef-4020-9b55-02b794b128202025-12-02WarningsExact identifier
unii: 0EWG668W17
AZO Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEi-Health, Inc.b4874fe2-d98b-4b5c-baad-d750709478422025-11-17WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEVERITYRX, LLC427b6ffb-3ff1-932f-e063-6394a90ae8b92025-10-31Adverse reactionsExact identifier
unii: 0EWG668W17
Uqora Maximum UTI Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEBonafide Health, LLC dba Uqora426317e7-a925-116a-e063-6294a90a52dc2025-10-27WarningsExact identifier
unii: 0EWG668W17
Uristat UltraPHENAZOPYRIDINE HYDROCHLORIDEMedtech Products Inc.c705185f-4908-451e-993b-b0b8a73f03922025-10-23WarningsExact identifier
unii: 0EWG668W17
Monistat MaintainPHENAZOPYRIDINE HYDROCHLORIDEInsight Pharmaceuticals LLCd1e563fc-5a91-4867-8177-93102bd24fe42025-10-23WarningsExact identifier
unii: 0EWG668W17
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: J2B2A4N98G
Phenazopyridine HydrochloridePHENAZOPYRIDINEBryant Ranch Prepack6ac0f3ce-0cc2-403c-946d-13b285ae98aa2025-09-19Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutionsd8155f91-d650-4021-91ee-f3b6c1055a362025-09-05Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutions900222e8-fc92-4d73-b3d5-1636e717bd652025-09-05Adverse reactionsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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