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 6 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEBryant Ranch Prepack25a1d5cf-7ede-4ece-8ec9-ccf979355d982024-01-04Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEKROGER COMPANY3334e3f6-f57c-45f9-9fa5-5ea3f93d335a2023-12-30WarningsExact identifier
unii: 0EWG668W17
PyridiumPHENAZOPYRIDINEAmneal Pharmaceuticals LLC165d01d4-a9f7-2293-e054-00144ff8d46c2023-12-16Adverse reactionsExact identifier
unii: 0EWG668W17
URO-PAIN Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.a8e51a62-366c-4533-a5a4-7f996f6f6bd02023-12-14WarningsExact identifier
unii: 0EWG668W17
URO-PAINPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.f0817ef7-c269-4881-81d9-ffc64b404b7e2023-12-14WarningsExact identifier
unii: 0EWG668W17
RIGHT REMEDIES Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrive Pharmaceuticals Inc.3fb23c2e-56b7-4f49-b3f1-5e5f07d61d202023-11-22WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC20681450-859a-45b0-825c-760cbbd95ac62023-10-31Warnings, 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.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: J2B2A4N98G
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.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: J2B2A4N98G
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.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: J2B2A4N98G
Phenazopyridine HydrochloridePHENAZOPYRIDINEProficient Rx LPe018e176-c4ec-42a2-9119-f1278cfa719a2023-06-01Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutions7aae87e6-92be-4e66-aca1-5be7f24a8c2d2023-04-26Adverse reactionsExact identifier
unii: 0EWG668W17
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: J2B2A4N98G
Cheeky Bonsai UTI Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEIXXA, INC3f1ec8d4-e362-4dd6-9ad8-22bf754cda0f2022-12-29WarningsExact identifier
unii: 0EWG668W17
Good Neighbor Pharmacy Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LP9281da67-6e41-43e3-b8af-290657aa80db2022-09-01WarningsExact identifier
unii: 0EWG668W17
Saccharum LactisSACCHARUM LACTISHahnemann Laboratories, INC.e6f02163-2845-680d-e053-2a95a90ae43a2022-08-23Exact identifier
unii: J2B2A4N98G
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEWinder Laboratories, LLC0a190e86-4074-4822-888e-4952281712ea2022-05-31Adverse reactionsExact identifier
unii: 0EWG668W17
6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e2021-12-28WarningsExact identifier
spl id: 6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e
spl set id: 6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e
8b917912-878e-433e-a228-24b93bc60d60c59cb31e-0e67-4cfa-8640-3304ccf6c4c52020-12-22WarningsExact identifier
spl id: 8b917912-878e-433e-a228-24b93bc60d60
spl set id: c59cb31e-0e67-4cfa-8640-3304ccf6c4c5
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: J2B2A4N98G

Reported adverse events (FAERS/openFDA)#

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