FDA.reportPublic FDA data

NDC 49348-941-02 - Sunmark Urinary Pain Relief Maximum Strength

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
49348-941
Requested NDC
49348-941-02
Package NDCs from labels
49348-941-02, 49348-941-01
Manufacturer
Bryant Ranch Prepack
Effective date
2021-12-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sunmark Urinary Pain Relief Maximum Strength - Bryant Ranch PrepackBryant Ranch Prepack2021-12-28HUMAN OTC DRUG LABEL
PHENAZOPYRIDINE HYDROCHLORIDE - McKesson | Reese Pharmaceutical Co | PharbestMcKesson | Reese Pharmaceutical Co | Pharbest2020-12-22HUMAN 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
49348-941-012023-01-30C16284748780-1f386c64a-0dcc-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-941-01Sunmark Urinary Pain Relief Maximum Strength1 in 1 CARTONTABLET16
49348-941-02Sunmark Urinary Pain Relief Maximum Strength12 in 1 BLISTER PACKTABLET126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-941SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]6Legacy NDC, 2 package rows20201224_c59cb31e-0e67-4cfa-8640-3304ccf6c4c5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-941-01EA - Each49348-941b0f4efe2-281c-430c-abb6-3cd393b22b1612022-06-06
49348-941-02EA - Each49348-94146f92040-f39b-4580-a3e4-baf6ee67231512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [MCKESSON]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 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEBryant Ranch Prepack24786685-978b-4485-995a-2964802bc2622024-01-04Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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