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
Label	Manufacturer	Effective date	Type
Diurex Water Pills	Kobayashi Healthcare International, Inc.	2025-04-10	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52389-306-01	DiurexWater Pills	42 in 1 BLISTER PACK	TABLET, COATED	42	13
52389-306-02	DiurexWater Pills	11 in 1 BLISTER PACK	TABLET, COATED	11	13
52389-306-21	DiurexWater Pills	2 in 1 CARTON	TABLET, COATED	2	13
52389-306-21	DiurexWater Pills	21 in 1 BLISTER PACK	TABLET, COATED	21	13
52389-306-22	DiurexWater Pills	2 in 1 CARTON	TABLET, COATED	2	13
52389-306-36	DiurexWater Pills	2 in 1 CARTON	TABLET, COATED	2	13
52389-306-36	DiurexWater Pills	18 in 1 BLISTER PACK	TABLET, COATED	18	13
52389-306-42	DiurexWater Pills	1 in 1 CARTON	TABLET, COATED	1	13
52389-306-84	DiurexWater Pills	2 in 1 CARTON	TABLET, COATED	2	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-306	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	13	Current NDC, Legacy NDC, 9 package rows	20250412_e02a39f9-1c8c-4d38-b394-3f5b7062932c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Caffeine	ACTIVE INGREDIENT	3G6A5W338E	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Magnesium salicylate	ACTIVE INGREDIENT	41728CY7UX	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Caffeine	ACTIVE MOIETY	3G6A5W338E	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Acacia	INACTIVE INGREDIENT	5C5403N26O	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Crospovidone	INACTIVE INGREDIENT	68401960MK	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Methylene blue	INACTIVE INGREDIENT	T42P99266K	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Polyethylene glycol 600	INACTIVE INGREDIENT	NL4J9F21N9	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Shellac	INACTIVE INGREDIENT	46N107B71O	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	DIUREX 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 30 of 191 · 3,820 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHISEIDO ULTIMATE SUN PROTECTOR MINERAL	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	5e31eee8-6532-47ea-99fc-22418791804b	2026-02-23	Warnings	Exact identifier unii: 15FIX9V2JP
Allergy Maximum Strength	URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	122ca23e-43f1-4e5c-afc2-1418b1717679	2026-02-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Perfect Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN PERFECT MEDICAL	4b47e7cb-17d6-6a7c-e063-6294a90abbea	2026-02-20	Warnings	Exact identifier unii: 15FIX9V2JP
Calcium Carbonate 500 mg	CALCIUM CARBONATE	NuCare Pharmaceuticals,Inc.	bad70158-3890-7e98-e053-2995a90a9c1c	2026-02-19	Warnings	Exact identifier unii: H0G9379FGK
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42	TITANIUM DIOXIDE, ZINC OXIDE	ALLAY SKIN SOLUTIONS LLC	425bf1d7-f2cf-4237-9047-dd53054acd1c	2026-02-18	Warnings	Exact identifier unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN	TITANIUM DIOXIDE	S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE	dacff3dc-49d7-6416-e053-2a95a90a85c6	2026-02-18	Warnings	Exact identifier unii: 15FIX9V2JP
Mitochondria Pro	ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,	Energique, Inc.	2f365207-b730-428d-9465-8853e86e79ff	2026-02-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
BIO COM 25 ACIDITY	NAT PHOS, NAT SULPH, SILICEA	BM Private Limited	3b3c3455-b321-071d-e063-6394a90a0160	2026-02-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
CINA	AMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEA	BM PRIVATE LIMITED	3b3c0874-90b5-deda-e063-6394a90a7802	2026-02-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Acne/Pimple Control	CALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDE	Forces of Nature	e871e46e-463e-49ec-a2af-5aa98548ee12	2026-02-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Fuligo	CIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEA	BM Private Limited	3b27225f-4587-d915-e063-6294a90a7225	2026-02-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Aflora	MULTIVITAMIN	Oncora Pharma, LLC	38e463d1-f608-7cb5-e063-6294a90a4abb	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: H0G9379FGK
Folixia	MULTIVITAMIN	Oncora Pharma, LLC	413945b5-116b-d8b6-e063-6394a90a55e8	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: H0G9379FGK
Nutralyn	MULTIVITAMIN	Oncora Pharma, LLC	33da017b-1e8c-d41c-e063-6394a90aab8c	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: H0G9379FGK
Folaten	MULTIVITAMIN	Oncora Pharma, LLC	93086235-2c33-424d-b0c3-213031988581	2026-02-12	Warnings, Adverse reactions	Exact identifier unii: H0G9379FGK
Acetaminophen , Caffeine and pyrilamine maleate	ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE	Softgel Healthcare Pvt Ltd	4a61313e-1b48-29df-e063-6394a90a27f0	2026-02-09	Warnings	Exact identifier unii: 3G6A5W338E
Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a9c970c8-b6e3-b0a1-e053-2a95a90a89c7	2026-02-09	Warnings	Exact identifier unii: 15FIX9V2JP
Ascomp with Codeine	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE	Breckenridge Pharmaceutical, Inc.	243a6aea-0f48-42a9-a85e-ff247ab94336	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3G6A5W338E
Mold, Yeast and Dust	ADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEA	NaturalCare	32afa0f0-bca5-4246-bc2e-decd757fcf9d	2026-02-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hampton Sun SPF 50 Mineral	ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	d6c33436-042e-44e8-8b55-98be6e246879	2026-02-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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