NDC 52389-241-01 - Uricalm 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
52389-241
Requested NDC
52389-241-01
Package NDCs from labels
52389-241-01, 52389-241-24, 52389-241-02, 52389-241-12, 52389-241-03, 52389-241-36, 52389-241-04, 52389-241-28, 52389-241-48
Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
UricalmKobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC2025-03-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-241-01UricalmMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2418
52389-241-02UricalmMaximum Strength12 in 1 BLISTER PACKTABLET, FILM COATED1218
52389-241-03UricalmMaximum Strength36 in 1 BLISTER PACKTABLET, FILM COATED3618
52389-241-04UricalmMaximum Strength28 in 1 BLISTER PACKTABLET, FILM COATED2818
52389-241-12UricalmMaximum Strength1 in 1 CARTONTABLET, FILM COATED118
52389-241-24UricalmMaximum Strength1 in 1 CARTONTABLET, FILM COATED118
52389-241-28UricalmMaximum Strength1 in 1 CARTONTABLET, FILM COATED118
52389-241-36UricalmMaximum Strength1 in 1 CARTONTABLET, FILM COATED118
52389-241-48UricalmMaximum Strength2 in 1 CARTONTABLET, FILM COATED218
52389-241-48UricalmMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2418

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-241URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]18Current NDC, Legacy NDC, 10 package rows20250331_1d94b45c-ee0b-499d-aca2-e8cd8dd490d2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenazopyridine hydrochlorideACTIVE INGREDIENT0EWG668W17URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
PhenazopyridineACTIVE MOIETYK2J09EMJ52URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
CranberryINACTIVE INGREDIENT0MVO31Q3QSURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
HypromellosesINACTIVE INGREDIENT3NXW29V3WOURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
Mineral oilINACTIVE INGREDIENTT5L8T28FGPURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPURICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
TriacetinINACTIVE INGREDIENTXHX3C3X673URICALM MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDOCHLORIDE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5

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 9 of 148 · 2,957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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