FDA.reportPublic FDA data

NDC 70518-3868-01 - 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
70518-3868
Requested NDC
70518-3868-01
Package NDCs from labels
70518-3868-0, 70518-3868-1, 70518-3868-2, 70518-3868-3, 70518-3868-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx OnlyREMEDYREPACK INC.2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3868-0Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET99
70518-3868-1Phenazopyridine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET219
70518-3868-2Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET69
70518-3868-3Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3868PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REMEDYREPACK INC.]7Current NDC, 4 package rows20250309_82dc87bb-ba27-4b86-9bc9-18492975ac9f.zip

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 · 205 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
rxcui: 1094107
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
rxcui: 1094107
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
rxcui: 1094107
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
rxcui: 1094107
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
rxcui: 1094107
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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