Uricalm

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 00:58:06

Label at a glance#

ProductUricalm Maximum Strength
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

Prompt temporary relief of: pain during urination burning sensation of urgency increased frequency associated with urinary tract infections.

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Do not exceed recommended dosage. Adults:  Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum. Swallow whole. Do not crush or chew. Do not use more than 12 tablets in 2 days. Drink 6 to 8 eight glasses of water daily. For use by normally healthy adults only.  Persons under 18 years of age should ...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine hydrochloride, 99.5 mg

Purpose

OTC - PURPOSE SECTION

Urinary Analgesic

Uses

INDICATIONS & USAGE SECTION

Prompt temporary relief of:

  • pain during urination
  • burning
  • sensation of urgency
  • increased frequency

associated with urinary tract infections.

Do not use if you have

OTC - DO NOT USE SECTION

  • liver or kidney problems
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to phenazopyridine hydrochloride.

When using this product

OTC - WHEN USING SECTION

  • stomach upset may occur; taking this product with or after meals may reduce stomach upset
  • you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other medications.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your symptoms do not go away after two days or become worse
  • you experience fever, chills, back pain or bloody urine
  • you suspect you are having an adverse reaction to this medication.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Do not exceed recommended dosage.
  • Adults:  Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum.
  • Swallow whole. Do not crush or chew.
  • Do not use more than 12 tablets in 2 days.
  • Drink 6 to 8 eight glasses of water daily.
  • For use by normally healthy adults only.  Persons under 18 years of age should use only as directed by a doctor.

Other information

INFORMATION FOR PATIENTS SECTION

WARNING: this product contains a chemical known to the State of California to cause cancer. Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver) . Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. **Contents sealed: Each URICALM dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with with foil backing. Do not use if seal appears broken or if product contents do not match product description. This product may stain soft contact lenses. This product can interfere with laboratory tests including urine, glucose (sugar) and ketones. You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carmine, Citric Acid, Cornstarch, Cranberry Extract, Croscarmellose Sodium, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silicon Dioxide, Talc, Titanium Dioxide and Triacetin.

OTC - QUESTIONS SECTION

Questions?  1-800-792-2582.

Product Insert

SPL PATIENT PACKAGE INSERT SECTION

Uricalm

199 mg Strong per dose

The Highest Dose of Clinically Proven Phenazopyridine Hydrochloride Available Over the Counter, Plus Cranberry

URICALM provides the maximum non-prescription strength of clinically proven Phenazopyridine Hydrochloride to relieve pain, burning, increased frequency, and sensation of urgency associated with urinary tract infections. Phenazopyridine Hydrochloride is the #1 doctor recommended ingredient for fast relief of UTI pain. Plus, URICALM contains cranberry, which is used extensively by those concerned about urinary tract health.

Active ingredient (in each tablet):Phenazopyridine Hydrochloride 99.5 mg

Purpose: Urinary analgesic

Uses: Prompt temporary relief of

  • pain during urination
  • burning
  • sensation of urgency
  • increased frequency associated with urinary tract infections.

Warnings

Do not use if you have

  • liver or kidney problems
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to phenazopyridine hydrochloride

When using this product

  • stomach upset may occur; taking this product with or after meals may reduce stomach upset
  • you may experience a reddish-orange discoloration of the urine which is a non-harmful temporary effect.

Ask a doctor or pharmacist before use if you are taking any other medications.

Stop use and ask a doctor if

  • your symptoms do not go away after two days or become worse
  • you experience fever, chills, back pain or bloody urine.
  • you suspect you are having an adverse reaction to this medication

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions:

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Do not exceed recommended dosage.
  • Adults: Swallow two (2) tablets with water after meals as needed up to 3 times daily for 2 days maximum.
  • Swallow whole. Do not crush or chew.
  • Do not use more than 12 tablets in 2 days
  • Drink 6 to 8 glasses of water daily.
  • For use by normally healthy persons only. Persons under 18 years of age should use only as directed by a doctor.

Other information: WARNING: This product contains a chemical known to the State of California to cause cancer. Precaution: Carcinogenesis: Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

**Contents sealed: Each URICALM dark red colored, round shaped tablet bears the identifying mark "ALVA" and a "1" on the reverse side, and is sealed in a clear plastic blister with foil backing. Do not use if seal appears broken or if product contents do not match product description. This product may stain soft contact lenses. This product can interfere with laboratory tests including urine, glucose (sugar) and ketones. You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients:Carmine, citric acid, corn starch, cranberry fruit extract, croscarmellose sodium, FD&C Red No. 40, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, talc, titanium dioxide and triacetin.

Questions? 1-800-792-2582

www.URICALM.com

Uricalm

199 mg de concentración por dosis

Contiene la dosis más alta de phenazopyridine hydrochloride clínicamente comprobado disponible en venta sin receta, además de arándano

URICALM ofrece la dosis más alta de chlorhidrato de fenazopyridina clínicamente comprobado de venta sin receta para aliviar el dolor, el ardor, el aumento en la frequencia y la sensación de necesidad urgente de orinar asociados con las infecciones del tracto urinario. El chlorhidrato de fenazopiridina es el ingrediente N. o 1 recomendado por el médico para el alivio rápido del dolor causado por las infecciones del tracto urinario (UTI, por sus singlas en ingles). Además, URICALM contiene arándano, que es usado ampliamente por quienes se preocupan por la salud del tracto urinario.

Ingrediente activo (in cada tableta): Phenazopyridine hydrochloride 99.5 mg

Propósito: Analgésico urinario

Usos: Alivio rápido y temporal del

  • dolor durante la micción
  • del ardor
  • de la sensación de necesidad urgente de orinar
  • del aumento en la frecuencia asociada con las infecciones del tracto urinario.

Advertencias:

No lo use si tiene

  • problemos hepático o renales
  • alergias a los alimentos, conservantes o colorantes
  • ha tenido una reacción hipersensible al phenazopyridine hydrochloride

Cuando se use este producto

  • puede presentarse malestar estomical; la ingestión de este producto con alimentos o después de comer puede reducir el malestar estomacal
  • puede experimentar un color de rojizo a anaranjado en la orina, lo cual es un efecto temporal inofensivo.

Consulte con un médico o farmacéutico antes de usarlo si está tomando cualquier otro medicamento.

Interrumpa el uso y consulte con su médico si

  • los síntomas no desaparecen o empeoran después de dos dias
  • tiene fiebre, escalofríos, dolor de espalda o nota la presencia de sangre en la orina.
  • sospecha que está experimentado una reacción adversa a este medicamento.

Si está embarazada o lactando, consulte con un profesional de la salud antes de usario.

Manténgalo fuera del alcance de los niños. En caso de sobredosis, obtenga ayuda médica o comuníquese de inmediato con un centro de toxicologia.

Indicaciones:

  • Lea todos las indicaciones y advertencias en el envase antes de usarlos.
  • Úselo únicamente como se indica.
  • No exceda la dosis recomendada.
  • Adultos: Ingiera dos (2) tabletas con agua después de las comidas según sea necesario hasta 3 veces al día por un máximo de 2 dias.
  • Trague la tablets entera. No triture ni mastique la tableta.
  • No use más de 12 tabletas en 2 días.
  • Tome de 6 a 8 vasos de agua todos los dias.
  • Para usarlo en adultos normalmente sanos únicamente. Las personas menores de 18 años deben usarlo solo según las indicaciones de un médico.

Información adicional: ADVERTENCIA: Este producto contiene una sustancia quimica que en el Estado de California se sabe que causa cáncer. Precaución: Carcinogénesis: La administración a largo plazo del phenazopyridine hydrochloride ha inducido neoplasia en ratas (intestino grueso) y en ratones (hígado). Aunque no ha sido informada una asociación entre el phenazopyridine hydrochloride y la neoplasia en seres humanos, no se han realizado estudios epidemiológicos adecuados sobre esto.

**El contenido está sellado Cada tableta URICALM de color rojo oscuro y redonda lleva la marca identificadora "ALVA" y un "1" en el dorso, y está sellada en un blíster de plástico transperente con un recubrimiento posterior de papel aluminio. No lo use si el sello parece estar roto o si el producto no coincide con la descripción del producto. Este producto puede causar manchas en los lentes de contacto blandos. Este producto puede interferir con las pruebas de laboratorio incluidas orina, glucosa (azúcar) y cetonas. Puede informar efectos secundarios graves al número de teléfono que aparece en la sección ¿Tiene preguntas? a continuación.

Ingredientes inactivos: carmin, ácido cítrico, almidón de maíz, extracto de arándano, croscarmelosa sódica, FD&C Rojo No. 40, FD&C Rojo No. 40 Lake, FD&C Amarillo No. 6 lake, hipromelosa, estearato de magnesio, maltodextrina, celulosa microcristalina, aceite mineral, polietilenglicol, polivinilpirrolidona, almidón pregelatinizado, dióxido de silicio, talco, dióxido de titanio y tracetino.

¿Tiene preguntas? 1-800-792-2582

www.URICALM.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN18
1094149Uricalm Maximum Strength 99.5 MG Oral TabletPSN18
1094149phenazopyridine hydrochloride 99.5 MG Oral Tablet [Uricalm]SBD18
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD18
1094147phenazopyridine HCl 99.5 MG Oral TabletSY18
1094149Uricalm 99.5 MG Oral TabletSY18

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 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
IngredientTypeUNIISPL versionUploaded
Phenazopyridine hydrochlorideACTIVE INGREDIENT0EWG668W175
PhenazopyridineACTIVE MOIETYK2J09EMJ525
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
CranberryINACTIVE INGREDIENT0MVO31Q3QS5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH485
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A85
HypromellosesINACTIVE INGREDIENT3NXW29V3WO5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
Mineral oilINACTIVE INGREDIENTT5L8T28FGP5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ5
POVIDONEINACTIVE INGREDIENTFZ989GH94E5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU45
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ5
TALCINACTIVE INGREDIENT7SEV7J4R1U5
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JP5
TriacetinINACTIVE INGREDIENTXHX3C3X6735

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 140 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates

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 1 · 1 matching rows.

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
ndc (package): 52389-241-02
ndc (package): 52389-241-36
ndc (package): 52389-241-04
ndc (package): 52389-241-12
ndc (package): 52389-241-48
ndc (package): 52389-241-24
ndc (package): 52389-241-03
ndc (package): 52389-241-28
ndc (package): 52389-241-01
ndc (product): 52389-241
ndc11 (package): 52389024104
ndc11 (package): 52389024124
ndc11 (package): 52389024112
ndc11 (package): 52389024101
ndc11 (package): 52389024136
ndc11 (package): 52389024148
ndc11 (package): 52389024102
ndc11 (package): 52389024103
ndc11 (package): 52389024128
spl id: 316e93e7-3627-8e6a-e063-6294a90a1d28
spl set id: 1d94b45c-ee0b-499d-aca2-e8cd8dd490d2

Reported adverse events (FAERS/openFDA)#

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