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 144 of 161 · 3,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228d15-a157-6989-e053-2995a90a44ea2023-12-01WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb94ab2bc-6ef3-4a64-ba05-a0a4e37794fa2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack6e28cc29-a85a-44d0-9c5b-bd0934ece64d2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
unii: 15FIX9V2JP
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
unii: 3G6A5W338E
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINESafrel Pharmaceuticals, LLC.0ac07846-5f04-dc4b-e063-6394a90ac8ca2023-11-22WarningsExact identifier
unii: 3G6A5W338E
Guardian Regular Strength AlkumsCALCIUM CARBONATEGuardian Drug Companyd7df3e77-2f9a-4f81-864e-7647b1ccb57d2023-11-22WarningsExact identifier
unii: H0G9379FGK
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
unii: 15FIX9V2JP
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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