FDA.reportPublic FDA data

Skopko Urinary Pain Relief

Manufacturer
Skopko | Reese Pharmaceutical Co
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:45:03

Label at a glance#

ProductSkopko Urinary Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

Dosage and administration

■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine Hydrochloride 95 mg

Purpose

OTC - PURPOSE SECTION

Urinary Analgesic

Uses

INDICATIONS & USAGE SECTION

fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

Warning

WARNINGS SECTION

Do not exceed recommended dosage

Ask Doctor before use if you have

OTC - ASK DOCTOR SECTION


■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine

When using this product

OTC - WHEN USING SECTION

■ When using this product   stomach upset may occur, taking this product with or after meals may reduce stomach upset
■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication  

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

in case of an overdose,get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate,microcrystalline cellulose.May also contain carnauba wax,

croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical

glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton
image of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSN4
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCD4
1094126phenazopyridine HCl 95 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-098-01Skopko Urinary Pain Relief1 in 1 CARTONTABLET14
37012-098-30Skopko Urinary Pain Relief30 in 1 CELLO PACKTABLET304
37012-098-50Skopko Urinary Pain Relief32 in 1 CELLO PACKTABLET324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-098SKOPKO URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [SKOPKO]4Current NDC, Legacy NDC, 3 package rows20241220_dc614b08-461c-4e29-8e5a-eccfdd680cef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W171
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ521
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N91
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37012-09837012-098-50, 37012-098-01, 37012-098-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENAZOPYRIDINE HYDROCHLORIDE0EWG668W17ACTIB
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM SILICATE9B9691B2N9IACT

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 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
Skopko Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDESkopkodc614b08-461c-4e29-8e5a-eccfdd680cef2024-12-18WarningsExact identifier
ndc (package): 37012-098-01
ndc (package): 37012-098-30
ndc (package): 37012-098-50
ndc (product): 37012-098
ndc11 (package): 37012009801
ndc11 (package): 37012009850
ndc11 (package): 37012009830
spl id: 0e0edb43-c2af-45ef-9bb0-264a65367ed6
spl set id: dc614b08-461c-4e29-8e5a-eccfdd680cef

Reported adverse events (FAERS/openFDA)#

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