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 44 of 191 · 3,820 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pleurisy Drops 2047PLEURISY DROPSProfessional Complementary Health Formulasb046d33f-170b-4b59-aa58-7632db9694fd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack15a34df5-e48f-4570-9232-80e4093c46242026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
RET Heart 7009RET HEARTProfessional Complementary Health Formulase2bf8331-1c50-4216-93a4-1d3cf64047592026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lumbar Drops 5013LUMBAR DROPSProfessional Complementary Health Formulasee6b54ea-fb6a-4723-8a0f-970aa82fea802026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rehydration Drops 2175REHYDRATION DROPSProfessional Complementary Health Formulas58cc2bd1-c530-43bf-876e-f30d4d95b8da2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cervical Drops 5002CERVICAL DROPSProfessional Complementary Health Formulasedd5f196-1423-4d4c-a8c1-89427c4f387e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fourth Chakra (Heart) 7304FOURTH CHAKRA (HEART)Professional Complementary Health Formulasef061447-42ae-43d0-b6f3-bf19a96ffe922026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Spinal Drops 5025SPINAL DROPSProfessional Complementary Health Formulasca6d7250-9c9e-40a6-8d41-88aba33d21dd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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