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 6 of 11 · 201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutionsd8155f91-d650-4021-91ee-f3b6c1055a362025-09-05Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutions900222e8-fc92-4d73-b3d5-1636e717bd652025-09-05Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEBryant Ranch Prepack3c9b98b0-72a5-44c5-a4de-7e950c5176c92025-07-24Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINENuCare Pharmaceuticals,Inc.c77eb633-9176-17ce-e053-2995a90a38802025-06-13Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEPD-Rx Pharmaceuticals, Inc.1522921b-d6c2-420d-ba0d-39ac16ba8b372025-05-01Adverse reactionsExact identifier
rxcui: 1094107
unii: 0EWG668W17
Uricalm Maximum StrengthPHENAZOPYRIDINE HYDOCHLORIDEKobayashi Healthcare International, Inc.1d94b45c-ee0b-499d-aca2-e8cd8dd490d22025-03-28WarningsExact identifier
unii: 0EWG668W17
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Phenazopyridine HydrochloridePHENAZOPYRIDINEPD-Rx Pharmaceuticals, Inc.c1591037-62f4-469f-8bb2-a82e49dfbecf2025-02-18Adverse reactionsExact identifier
rxcui: 1094104
unii: 0EWG668W17
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINEProficient Rx LPb7a5da89-dc52-4b61-8a54-262d0826c6352025-02-01Adverse reactionsExact identifier
rxcui: 1094107
unii: 0EWG668W17
GOOD REMEDIES Maximum Strength Urinary Pain Relief CapletPHENAZOPYRIDINE HYDROCHLORIDEStrive Pharmaceuticals Inc.269fa921-f4c4-16e7-e063-6394a90a0cbb2025-01-06WarningsExact identifier
unii: 0EWG668W17
Wallgreens Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEWalgreens Co.04b41b83-b168-429e-a785-9e210bac2deb2024-12-18WarningsExact identifier
unii: 0EWG668W17
CVS Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDECVS PHARMACY INCbddc4208-0559-4f41-a99e-68cfccfade3c2024-12-18WarningsExact identifier
unii: 0EWG668W17
Good Neighbor Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEAmerisourceBergen Drug Corp3a37d7ce-37a2-4ebf-abab-bf45c5b1ae652024-12-18WarningsExact identifier
unii: 0EWG668W17
Leader Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDECardinal Health4ece7c89-b01b-48b5-8736-2253b14fa5512024-12-18WarningsExact identifier
unii: 0EWG668W17
Skopko Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDESkopkodc614b08-461c-4e29-8e5a-eccfdd680cef2024-12-18WarningsExact identifier
unii: 0EWG668W17
Sunmark Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCcbc5de43-0f89-4e71-a764-749ef0ba2dfa2024-12-18WarningsExact identifier
unii: 0EWG668W17
TopCare Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETOPCO ASSOCIATES LLC2d272b96-c676-4ed8-aa08-df2d41a2ef412024-12-18WarningsExact identifier
unii: 0EWG668W17
Kroger Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETHE KROGER CO35437f23-bcaa-4bab-aef1-02a275455b772024-12-18WarningsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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