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 5 of 148 · 2,957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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