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 152 of 160 · 3,189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New Hanbang Col CapACETAMINOPHEN, CAFFEINE ANHYDROUS,Lydia Co., Ltd.e9dbbbcd-9ab7-aa10-e053-2995a90acd242023-07-10WarningsExact identifier
unii: 3G6A5W338E
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC5f3c7457-6670-4a0d-bdff-c3e0fe91b7c62023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Equate Homeopathic Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURWalmart Inc.ffbe8b3e-3694-e9be-e053-6394a90a94552023-07-05WarningsExact identifier
unii: H0G9379FGK
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepack90e166ac-8789-4e7a-b5bb-37c475e3a5b02023-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
unii: 15FIX9V2JP
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
unii: 15FIX9V2JP
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEAurohealth LLCe47e2169-4b31-4c23-bb9d-c26aa106ea372023-05-11WarningsExact identifier
unii: 3G6A5W338E
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEAAA PHARMACEUTICAL, INC.f9c9a0b4-dbfe-7da9-e053-6294a90a7e092023-05-03WarningsExact identifier
unii: 3G6A5W338E
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3875c01b-7cd6-4bed-8d4e-c580c55408602023-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
DG Health migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, LLCd0e82cac-dfbb-49cb-99c8-560b02fb1a8c2023-04-05WarningsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGolden State Medical Supply, Inc.ee131bce-863b-b5a1-e053-2a95a90afc792023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
basic care migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCedcc7b4b-1317-4060-b947-8c16effc57422023-02-27WarningsExact identifier
unii: 3G6A5W338E
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGranules Pharmaceuticals Inc.74e27dab-9790-47e4-b4f1-3b9df4bce1842023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
NOVOMINSYRUPCAFFEINE ANHYDROUS, MECLIZINE HYDROCHLORIDE HYDRATE, PYRIDOXINE HYDROCHLORIDELydia Co., Ltd.f2e9fbc8-501f-c386-e053-2995a90a6a142023-01-23WarningsExact identifier
unii: 3G6A5W338E
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEFSA STORE INC.ec6b7017-cf12-09a7-e053-2995a90a2db92023-01-12WarningsExact identifier
unii: 3G6A5W338E
Vitrexyl plus IronFERROUS FUMARATE, FOLIC ACIDPureTek Corporationada43056-a3ce-e7de-e053-2a95a90aa0462023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
VitrexylFOLIC ACIDPureTek Corporationae064a9e-daba-fa86-e053-2a95a90a16a72023-01-11Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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