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 10 of 11 · 201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
PyridiumPHENAZOPYRIDINEAmneal Pharmaceuticals LLC165d01d4-a9f7-2293-e054-00144ff8d46c2023-12-16Adverse reactionsExact identifier
rxcui: 1094107
rxcui: 1094104
unii: 0EWG668W17
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
URO-PAIN Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.a8e51a62-366c-4533-a5a4-7f996f6f6bd02023-12-14WarningsExact identifier
unii: 0EWG668W17
URO-PAINPHENAZOPYRIDINE HYDROCHLORIDERising Pharma Holdings, Inc.f0817ef7-c269-4881-81d9-ffc64b404b7e2023-12-14WarningsExact identifier
unii: 0EWG668W17
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
RIGHT REMEDIES Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrive Pharmaceuticals Inc.3fb23c2e-56b7-4f49-b3f1-5e5f07d61d202023-11-22WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC20681450-859a-45b0-825c-760cbbd95ac62023-10-31Warnings, Adverse reactionsExact identifier
rxcui: 1094107
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEProficient Rx LPe018e176-c4ec-42a2-9119-f1278cfa719a2023-06-01Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutions7aae87e6-92be-4e66-aca1-5be7f24a8c2d2023-04-26Adverse reactionsExact identifier
rxcui: 1094107
unii: 0EWG668W17
Cheeky Bonsai UTI Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEIXXA, INC3f1ec8d4-e362-4dd6-9ad8-22bf754cda0f2022-12-29WarningsExact identifier
unii: 0EWG668W17
Good Neighbor Pharmacy Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEProficient Rx LP9281da67-6e41-43e3-b8af-290657aa80db2022-09-01WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEWinder Laboratories, LLC0a190e86-4074-4822-888e-4952281712ea2022-05-31Adverse reactionsExact identifier
rxcui: 1094107
rxcui: 1094104
unii: 0EWG668W17
Walgreens Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEWalgreens8c674487-b941-47de-b765-f9038feb5c2c2017-03-31WarningsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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