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 37 of 191 · 3,820 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior038939d6-b9a5-4cb6-a818-6f7cf3f106fa2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03c7ca69-86f1-420c-9c4c-0bf2e8553c942026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff6a85a4-b0c5-4c2e-a698-bb315203f51b2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior262b4cfc-71c3-485e-906f-a88fe33035a82026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee032026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cb4bad3-57d6-4e67-88ec-1776870c3eba2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorffd1ba9e-dd64-422a-bd69-596b5d80554d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64943a01-5193-4c04-b623-33ceb09f10fd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordf2e2d3f-8876-4197-bdfa-339b4f6a75712026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb5d7fa-4d40-46bd-9ef3-14368578cb332026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae1e74f1-eb31-4da1-8b24-dae692d3637e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora5ce5568-708a-4af1-aa06-ea643c898bb12026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4fc4ce51-000a-42ee-952f-b4ce5f5d8a602026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorade16145-5267-4f01-bd99-f507087583f32026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72471612-1ae0-493c-87c7-bf7257310e702026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior881ad126-d93f-4782-8ece-600d41a254d72026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior27bb6424-9aa6-408a-a9f4-874cb60c8f1f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorea170049-ec16-4c9d-a73d-368f6b747d572026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6fb14f0-a3e3-4545-bb4a-f9c27190b11b2026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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