FDA.reportPublic FDA data

NDC 61919-184-10 - Phenazopyridine Hydrochloride

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
61919-184
Requested NDC
61919-184-10
Package NDCs from labels
61919-184-10, 61919-184-12
Manufacturer
Direct Rx
Effective date
2020-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenazopyridine Hydrochloride - Direct RxDirect Rx2020-01-21HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-184-122023-01-30C16284748780-1f386c649-b3d7-0266-e053-dadaa90a7c1aPhenazopyridine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-184-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET103
61919-184-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-184PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]3Legacy NDC, 2 package rows20200130_d31ddcfe-08e2-45cc-ae57-2fda7b1edf4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-184-10EA - Each61919-18430baa410-0e3d-4f56-a4cc-390b0913fcc712014-05-02
61919-184-12EA - Each61919-184a82041a6-58cd-42d4-9853-27926a2b6c6712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1

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 11 · 206 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.49baf6e5-133a-4e1a-9740-506673d27caf2026-08-21Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.c0e5d32e-075f-4c76-8332-a06560001efe2026-08-14Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.132cc592-6b03-4b75-bf39-df476fb9dc812026-08-14Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc96308f8c-66e7-486a-a5c0-ee9a133ad0512026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ce702be2-eec2-4346-965e-f1f6ba342fc92026-08-14Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Phenazopyridine HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.f6829698-b12e-484d-a322-d2f68586e6372026-08-07Adverse reactionsExact identifier
unii: 0EWG668W17
Gencare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEPioneer Life Sciences, LLC6bbf15b4-2954-40ff-8460-1ef0ed8906542026-08-03WarningsExact identifier
unii: 0EWG668W17
Nuvicare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDENUVICARE LLC5fe4e4dc-f1c4-4617-b6a6-6ea16a63abfe2026-08-03WarningsExact identifier
unii: 0EWG668W17
Cystex Max Strength UTI Pain ReliefCYSTEX MAX STRENGTH UTI PAIN RELIEFClarion Brands LLC57482f71-80d3-b20d-e063-6394a90a0cf42026-07-27WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEREMEDYREPACK INC.6eb59b69-4ad0-47b1-bd3c-1d04d0852ec52026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.56ad921f-0b6e-aa2b-e063-6394a90aec6b2026-07-15Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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