FDA.reportPublic FDA data

NDC 52389-656-01 - Diurex Ultimate

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
52389-656
Requested NDC
52389-656-01
Package NDCs from labels
52389-656-01, 52389-656-60
Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2026-06-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diurex UltimateKobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC2026-06-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-656-01DiurexUltimate30 in 1 BLISTER PACKTABLET, FILM COATED3012
52389-656-60DiurexUltimate2 in 1 CARTONTABLET, FILM COATED212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-656DIUREX ULTIMATE (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]12Current NDC, Legacy NDC, 2 package rows20250416_c6debbfe-6061-463f-8f17-fb240c6f1bab.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 24 of 164 · 3,261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCe874118f-b4fe-4c80-aece-99ea20e7e8052026-03-12WarningsExact identifier
unii: H0G9379FGK
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
unii: H0G9379FGK
AMAZON Ultra Strength Tropical FruitANTACID TABLETS (CALCIUM CARBONATE)AMAZON.COM SERVICES LLCdd93a70e-8b43-495e-bda3-526e5d6de9532026-03-12WarningsExact identifier
unii: H0G9379FGK
complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEHyVee Inc237efe92-b302-4e11-93fe-7b0f727a00aa2026-03-12WarningsExact identifier
unii: H0G9379FGK
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Stay Awake Maximum StrengthCAFFEINEBetter Living Brands, LLC976780f9-228c-44cb-b1f4-8027280fc7cb2026-03-11WarningsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEMajor Pharmaceuticals0ca49c3c-f2cb-40e3-a7d5-5f48eca590162026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
5% Minoxidil Hair Growth Serum5% MINOXIDIL HAIR GROWTH SERUMGuangzhou Ariel Biotech Co., Ltd.22c42a75-23cc-c596-e063-6394a90a04082026-03-06WarningsExact identifier
unii: 3G6A5W338E
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2a27da49-23d6-4035-8088-806ee22b98b02026-03-06WarningsExact identifier
unii: 3G6A5W338E
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
unii: 3G6A5W338E
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Company6f1dcfda-c12a-4c3b-80a2-c9e15517c88f2026-03-03WarningsExact identifier
unii: H0G9379FGK
SEYIPCALCIUM CARBONATESeaip co., Ltdd98d8626-8c42-77a5-e053-2a95a90a78e22026-03-03WarningsExact identifier
unii: H0G9379FGK
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2b35acdc-ff88-46e6-a108-5240aac1d53f2026-03-03WarningsExact identifier
unii: 3G6A5W338E
Nova AntacidCALCIUM CARBONATEBlueberri Inc.48696198-fc2b-eb24-e063-6294a90a3eae2026-03-02WarningsExact identifier
unii: H0G9379FGK
REGULAR STRENGTH ANTACID PEPPERMINTCALCIUM CARBONATEAKRON PHARMA INC3fb78d78-5296-4197-e063-6294a90adaae2026-03-02WarningsExact identifier
unii: H0G9379FGK
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacye130831a-ec50-467a-9e5c-ba6ebc7bef3c2026-02-26WarningsExact identifier
unii: 3G6A5W338E

Reported adverse events (FAERS/openFDA)#

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