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

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