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 27 of 164 · 3,261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: H0G9379FGK
LEADER Ultra Strength Peppermint FlavorCHEWABLE ANTACID TABLETSCardinal Health3bf16b23-5a67-454f-b335-677cc49cd7a32026-02-02WarningsExact identifier
unii: H0G9379FGK
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
unii: 15FIX9V2JP
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEDOLGENCORP, LLC89eb8196-54c6-4e30-8655-502cc4313c8a2026-02-02WarningsExact identifier
application number: M027
unii: 3G6A5W338E
GOODYS MAXACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.02b3a604-3f09-47e7-add1-b9038b3a268b2026-02-02WarningsExact identifier
unii: 3G6A5W338E
Tums Chewy Bites Raspberry LemonadeCALCIUM CARBONATEHaleon US Holdings LLC3a9b6838-d450-9c3c-e063-6294a90acb622026-02-02WarningsExact identifier
unii: H0G9379FGK
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
unii: 15FIX9V2JP
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATEWAL-MART STORES INC.7cfcbb36-c84c-4dc4-873a-ae1c5204aa002026-01-30WarningsExact identifier
unii: H0G9379FGK
Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)bfcffa70-94a9-43de-9f22-4ed6a71c0a8d2026-01-29WarningsExact identifier
unii: 3G6A5W338E
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
unii: 15FIX9V2JP
CaffeineCAFFEINELEADER/ Cardinal Health 110, Inc.7c4d61f7-9c6a-61ac-e053-2991aa0a95332026-01-28WarningsExact identifier
unii: 3G6A5W338E
PamabromPAMABROMSoftgel Healthcare Pvt Ltd186805ed-84fc-e723-e063-6294a90ad3202026-01-27WarningsExact identifier
application number: M027
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
unii: 15FIX9V2JP
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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