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 8 of 11 · 201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEReese Pharmaceutical Co0f0a19cd-0c6d-43f9-a6d5-183fb5fa4fe52024-12-18WarningsExact identifier
unii: 0EWG668W17
Walgreens Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEWalgreens Co.21dc5369-6610-498b-9d9a-c044a6abe6e42024-12-18WarningsExact identifier
unii: 0EWG668W17
HealthMart Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCb7735e84-c320-4546-80c9-58c172097fa82024-12-18WarningsExact identifier
unii: 0EWG668W17
TopCare Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETOPCO ASSOCIATES LLC1662f712-6756-4dcd-bdfa-b4ed28c0d69a2024-12-18WarningsExact identifier
unii: 0EWG668W17
Premier Value Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Consortium, LLCbd7a027f-1175-4f9f-b61d-50bda0feaff22024-12-18WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEBryant Ranch Prepack7367afd6-6bf6-4240-a274-79b7a5de97152024-12-12Adverse reactionsExact identifier
rxcui: 1094107
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LP6c3adf9f-7179-43b7-8397-4148a9146a2c2024-11-01Warnings, Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEAmneal Pharmaceuticals LLCb424b50f-990b-4018-a815-0311693cabb32024-10-30Adverse reactionsExact identifier
ndc (product): 65162-682
rxcui: 1094107
rxcui: 1094104
spl id: 9b599d15-523d-4e57-a844-800d995d35e5
spl set id: b424b50f-990b-4018-a815-0311693cabb3
unii: 0EWG668W17
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEA-S Medication Solutions7e0f2ba8-003c-4303-80fd-76f70ddc2c112024-10-14Warnings, Adverse reactionsExact identifier
rxcui: 1094107
unii: 0EWG668W17
Rite Aid Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDERite Aidb0634f37-53c4-47c4-a68e-710c944f213b2024-10-11WarningsExact identifier
unii: 0EWG668W17
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.b11bdb87-4ebc-3a14-e053-2a95a90a7d732024-07-17WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HCLPHENAZOPYRIDINE HCLDirect Rx0e34badf-c886-08c1-e063-6294a90aeefd2024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Foster and Thrive Neighbor Pharmacy Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCc1a0f3be-d848-4728-a5e8-c14d63ec0af72024-06-21WarningsExact identifier
unii: 0EWG668W17
Foster and Thrive Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLC97ea2a3e-c1a0-437d-ac2a-2128e193183b2024-06-21WarningsExact identifier
unii: 0EWG668W17
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEAdvanced Rx LLCa10464cf-36b2-460f-b31c-2e0edee3e4cf2024-05-01WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LPac155091-ee07-46da-bb25-ff4cd40746102024-05-01Warnings, Adverse reactionsExact identifier
rxcui: 1094107
rxcui: 1094104
unii: 0EWG668W17
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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