FDA.reportPublic FDA data

Uricalm

Product NDC
52389-241
11-digit product format
523890241
Labeler code
52389
Product ID
52389-241_316e93e7-3627-8e6a-e063-6294a90a1d28
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine Hydochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kobayashi Healthcare International, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-04-29
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52389-24152389-241-12DDiscontinued by firm2026-07-31
excluded packagepackage52389-24152389-241-36DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Uricalm Maximum StrengthPHENAZOPYRIDINE HYDOCHLORIDEKobayashi Healthcare International, Inc.1d94b45c-ee0b-499d-aca2-e8cd8dd490d22025-03-28WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings

Additional Listing Data#

Finished product
Yes
Brand name base
Uricalm
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094147, 1094149

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN1d94b45c-ee0b-499d-aca2-e8cd8dd490d218
1094149Uricalm Maximum Strength 99.5 MG Oral TabletPSN1d94b45c-ee0b-499d-aca2-e8cd8dd490d218
1094149phenazopyridine hydrochloride 99.5 MG Oral Tablet [Uricalm]SBD1d94b45c-ee0b-499d-aca2-e8cd8dd490d218
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD1d94b45c-ee0b-499d-aca2-e8cd8dd490d218
1094147phenazopyridine HCl 99.5 MG Oral TabletSY1d94b45c-ee0b-499d-aca2-e8cd8dd490d218
1094149Uricalm 99.5 MG Oral TabletSY1d94b45c-ee0b-499d-aca2-e8cd8dd490d218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-241-015238902410124 in 1 BLISTER PACKHistorical
52389-241-025238902410212 in 1 BLISTER PACKHistorical
52389-241-035238902410336 in 1 BLISTER PACKHistorical
52389-241-045238902410428 in 1 BLISTER PACKHistorical
52389-241-12523890241121 in 1 CARTONHistorical
52389-241-24523890241241 BLISTER PACK in 1 CARTON (52389-241-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-01) 1 blister pack2008-04-290000-00-00NoNoCurrent
52389-241-28523890241281 BLISTER PACK in 1 CARTON (52389-241-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK (52389-241-04) 1 blister pack2014-02-200000-00-00NoNoCurrent
52389-241-36523890241361 in 1 CARTONHistorical
52389-241-48523890241482 BLISTER PACK in 1 CARTON (52389-241-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-10-180000-00-00NoNoCurrent