FDA.reportPublic FDA data

NDC 37012-098-50 - Skopko 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
37012-098
Requested NDC
37012-098-50
Package NDCs from labels
37012-098-50, 37012-098-01, 37012-098-30
Manufacturer
Skopko | 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
Skopko Urinary Pain Relief - Skopko | Reese Pharmaceutical CoSkopko | Reese Pharmaceutical Co2024-12-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-098-01Skopko Urinary Pain Relief1 in 1 CARTONTABLET14
37012-098-30Skopko Urinary Pain Relief30 in 1 CELLO PACKTABLET304
37012-098-50Skopko Urinary Pain Relief32 in 1 CELLO PACKTABLET324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-098SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]4Current NDC, Legacy NDC, 3 package rows20241220_dc614b08-461c-4e29-8e5a-eccfdd680cef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]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 1 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.49baf6e5-133a-4e1a-9740-506673d27caf2026-08-21Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.c0e5d32e-075f-4c76-8332-a06560001efe2026-08-14Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.132cc592-6b03-4b75-bf39-df476fb9dc812026-08-14Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc96308f8c-66e7-486a-a5c0-ee9a133ad0512026-08-14Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ce702be2-eec2-4346-965e-f1f6ba342fc92026-08-14Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Phenazopyridine HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.f6829698-b12e-484d-a322-d2f68586e6372026-08-07Adverse reactionsExact identifier
unii: 0EWG668W17
Gencare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEPioneer Life Sciences, LLC6bbf15b4-2954-40ff-8460-1ef0ed8906542026-08-03WarningsExact identifier
unii: 0EWG668W17
Nuvicare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDENUVICARE LLC5fe4e4dc-f1c4-4617-b6a6-6ea16a63abfe2026-08-03WarningsExact identifier
unii: 0EWG668W17
Cystex Max Strength UTI Pain ReliefCYSTEX MAX STRENGTH UTI PAIN RELIEFClarion Brands LLC57482f71-80d3-b20d-e063-6394a90a0cf42026-07-27WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.6eb59b69-4ad0-47b1-bd3c-1d04d0852ec52026-07-27Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.56ad921f-0b6e-aa2b-e063-6394a90aec6b2026-07-15Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDEGenus Lifesciences Inc.991b3b97-9cea-4c48-90a4-ebff55417d982026-07-14Adverse reactionsExact identifier
unii: 0EWG668W17
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.7e131f69-d259-404d-a859-0497f5cbe8562026-06-24Adverse reactionsExact identifier
unii: 0EWG668W17
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.548edf26-c81e-f982-e063-6394a90af9da2026-06-18Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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