FDA.reportPublic FDA data

NDC 52389-306-01 - Diurex Water Pills

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
52389-306
Requested NDC
52389-306-01
Package NDCs from labels
52389-306-01, 52389-306-84, 52389-306-42, 52389-306-02, 52389-306-22, 52389-306-21, 52389-306-36
Manufacturer
Kobayashi Healthcare International, Inc.
Effective date
2025-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diurex Water PillsKobayashi Healthcare International, Inc.2025-04-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-306-01DiurexWater Pills42 in 1 BLISTER PACKTABLET, COATED4213
52389-306-02DiurexWater Pills11 in 1 BLISTER PACKTABLET, COATED1113
52389-306-21DiurexWater Pills2 in 1 CARTONTABLET, COATED213
52389-306-21DiurexWater Pills21 in 1 BLISTER PACKTABLET, COATED2113
52389-306-22DiurexWater Pills2 in 1 CARTONTABLET, COATED213
52389-306-36DiurexWater Pills2 in 1 CARTONTABLET, COATED213
52389-306-36DiurexWater Pills18 in 1 BLISTER PACKTABLET, COATED1813
52389-306-42DiurexWater Pills1 in 1 CARTONTABLET, COATED113
52389-306-84DiurexWater Pills2 in 1 CARTONTABLET, COATED213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-306DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]13Current NDC, Legacy NDC, 9 package rows20250412_e02a39f9-1c8c-4d38-b394-3f5b7062932c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CaffeineACTIVE INGREDIENT3G6A5W338EDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Magnesium salicylateACTIVE INGREDIENT41728CY7UXDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
CaffeineACTIVE MOIETY3G6A5W338EDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
AcaciaINACTIVE INGREDIENT5C5403N26ODIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Calcium carbonateINACTIVE INGREDIENTH0G9379FGKDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
CrospovidoneINACTIVE INGREDIENT68401960MKDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WODIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Methylene blueINACTIVE INGREDIENTT42P99266KDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Mineral oilINACTIVE INGREDIENTT5L8T28FGPDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Polyethylene glycol 600INACTIVE INGREDIENTNL4J9F21N9DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
ShellacINACTIVE INGREDIENT46N107B71ODIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Starch, cornINACTIVE INGREDIENTO8232NY3SJDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Stearic acidINACTIVE INGREDIENT4ELV7Z65APDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
TriacetinINACTIVE INGREDIENTXHX3C3X673DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]2

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 41 of 191 · 3,820 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Extra Strength Sugar Free AntacidANTACIDCVS Pharmacy,Inc.f722e7ce-6cca-4850-a230-7510c7ca77542026-01-12WarningsExact identifier
unii: H0G9379FGK
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
unii: 3G6A5W338E
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Play Mineral Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC89088ac5-f1ee-1996-e053-2a95a90a8fdc2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1TITANIUM DIOXIDEAmway Corp4345cdf6-e220-4e7c-8abd-da59d2b7db842026-01-09WarningsExact identifier
unii: 15FIX9V2JP
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATEActavis Pharma, Inc.a58819b8-a52c-44a7-9ab0-c74480d985062026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lawn and Garden Detox 6026LAWN AND GARDEN DETOXProfessional Complementary Health Formulas2db4bdd8-1049-450a-8642-0e1dbbe5abb32026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Caffeine Mix 1003CAFFEINE MIXProfessional Complementary Health Formulasce7f9a40-6cb1-49d1-a36a-e0f292dd136e2026-01-08WarningsExact identifier
unii: 3G6A5W338E

Reported adverse events (FAERS/openFDA)#

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