FDA.reportPublic FDA data

NDC 36800-103-12 - TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF

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
36800-103
Requested NDC
36800-103-12
Package NDCs from labels
36800-103-12, 36800-103-01
Manufacturer
TOPCO ASSOCIATES LLC | Reese Pharmaceutical Co | Contract Pharmacal Corp.
Effective date
2019-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DRUG FACTSTOPCO ASSOCIATES LLC | Reese Pharmaceutical Co | Contract Pharmacal Corp.2019-01-30HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-103-012023-01-30C16284748780-1f386c649-e214-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-103-01TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF1 in 1 CARTONTABLET12
36800-103-12TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF12 in 1 BLISTER PACKTABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-103TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2Legacy NDC, 2 package rows20190131_2d3fcf6d-5965-425c-896b-a3b895e4fd44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]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 2 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZOURINARY PAIN RELIEFi-Health, Inc.3d0298b7-eaec-488b-9cab-19af4614ff532026-01-05WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINENorthwind Health Company, LLCf2f3e29f-9553-f7c3-e053-2995a90aff362026-01-01Adverse reactionsExact identifier
unii: 0EWG668W17
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: J2B2A4N98G
Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETARGET CORPORATIONe6e27e7f-d04c-5a49-e053-2a95a90a776a2025-12-30WarningsExact identifier
unii: 0EWG668W17
Vexia Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEReese Pharmaceutical Co5fbc47d2-cecd-4187-9bcc-51b1d0b7695d2025-12-29WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINENorthwind Health Company, LLCf29f2ed6-6fd1-fd65-e053-2a95a90aedc42025-12-26Adverse reactionsExact identifier
unii: 0EWG668W17
PHENAZOPYRIDINE HYDROCHLORIDEPHENAZOPYRIDINE HYDROCHLORIDEChartwell RX, LLC9ed3cf8c-e1c1-4290-b094-25ac6f7a9a562025-12-11Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEA-S Medication Solutionsd514fd31-feeb-4371-9b28-eec9834a70032025-12-10Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEA-S Medication Solutionscd78a132-037c-412a-9c56-e38367e05c922025-12-10Warnings, Adverse reactionsExact identifier
unii: 0EWG668W17
Quality Choice Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Marketing Association45e0cc2f-4a25-40ef-86ed-d1212815d7512025-12-02WarningsExact identifier
unii: 0EWG668W17
Quality Choice Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEChain Drug Marketing Association3cee4fea-f1ef-4020-9b55-02b794b128202025-12-02WarningsExact identifier
unii: 0EWG668W17
AZO Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEi-Health, Inc.b4874fe2-d98b-4b5c-baad-d750709478422025-11-17WarningsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEVERITYRX, LLC427b6ffb-3ff1-932f-e063-6394a90ae8b92025-10-31Adverse reactionsExact identifier
unii: 0EWG668W17
Uqora Maximum UTI Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEBonafide Health, LLC dba Uqora426317e7-a925-116a-e063-6294a90a52dc2025-10-27WarningsExact identifier
unii: 0EWG668W17
Uristat UltraPHENAZOPYRIDINE HYDROCHLORIDEMedtech Products Inc.c705185f-4908-451e-993b-b0b8a73f03922025-10-23WarningsExact identifier
unii: 0EWG668W17
Monistat MaintainPHENAZOPYRIDINE HYDROCHLORIDEInsight Pharmaceuticals LLCd1e563fc-5a91-4867-8177-93102bd24fe42025-10-23WarningsExact identifier
unii: 0EWG668W17
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: J2B2A4N98G
Phenazopyridine HydrochloridePHENAZOPYRIDINEBryant Ranch Prepack6ac0f3ce-0cc2-403c-946d-13b285ae98aa2025-09-19Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutionsd8155f91-d650-4021-91ee-f3b6c1055a362025-09-05Adverse reactionsExact identifier
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEA-S Medication Solutions900222e8-fc92-4d73-b3d5-1636e717bd652025-09-05Adverse reactionsExact identifier
unii: 0EWG668W17

Reported adverse events (FAERS/openFDA)#

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