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 125 of 161 · 3,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cramp TabsACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATEJHK DBA American Safety & First Aidc090807d-03b7-42d4-be41-f6240a3b330f2024-10-04WarningsExact identifier
application number: M027
VivarinCAFFEINENavajo Manufacturing Company Inc.1639b0ac-8d6a-e5fe-e063-6294a90aeead2024-10-03WarningsExact identifier
unii: 3G6A5W338E
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LP3cf799b4-c785-4ae2-908b-c42e426733dc2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
PrenatrixFERROUS FUMARATE, FOLIC ACIDPureTek Corporationae07585b-e6e4-fd6d-e053-2995a90a7eec2024-09-30Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
PretrateFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba4a1424-0782-77c0-e053-2a95a90a6e442024-09-30Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
caffeineCAFFEINEAurohealth LLC2dbf82e7-8f3a-47fb-8045-9136f4b9ae492024-09-20WarningsExact identifier
unii: 3G6A5W338E
DoloDent Toothache For adultsACETAMINOPHEN, CAFFEINEPharmadel LLC1e7a0c06-ad3c-b94f-e063-6394a90abab12024-09-19WarningsExact identifier
unii: 3G6A5W338E
HEB Extra Strength sugar free Antacid 174CALCIUM CARBONATEH E B17cd3717-2fc3-1693-e063-6394a90ae03d2024-09-17WarningsExact identifier
unii: H0G9379FGK
Goodsense Extra Strength AntacidCALCIUM CARBONATEGoodSense193a1805-9f57-29cd-e063-6394a90ab99f2024-09-13WarningsExact identifier
unii: H0G9379FGK
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBreckenridge Pharmaceutical, Inc.d74db417-d2de-495b-bb75-46a83745603d2024-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESOLCO HEALTHCARE US, LLC5c9c3407-212a-4ae9-a574-2b0c53f3c5eb2024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: B697894SGQ
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: 15FIX9V2JP
HEADACHE RELIEFACETAMINOPHEN-ASPIRIN-CAFFEINETARGET CORPORATION8e953cef-135e-f1aa-e053-2995a90aaa8b2024-09-05WarningsExact identifier
unii: 3G6A5W338E
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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