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 63 of 190 · 3,795 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SCROPHULOUS HP	BARIUM CARBONATE, BROMINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, FERROUS IODIDE, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE	Natural Creations, Inc.	fb30a5cf-7d25-48f3-a6e6-0cc4c1f41892	2025-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
INJURY HP	ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, SILICON DIOXIDE, DELPHINIUM STAPHISAGRIA SEED, COMFREY ROOT	Natural Creations, Inc.	10be3e95-da2f-4340-8c12-2e676472a94d	2025-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
SINUS HP	AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG	Natural Creations, Inc.	f017da22-74c2-40f4-adcc-5e84b6ea5291	2025-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Respirasode	BRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDIS	Natural Creations, Inc	ce06327f-7e5e-420a-9b61-0d410f9e10d6	2025-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydrate 1	BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGEN	Natural Creations, Inc	189bc53c-5d75-48df-a74e-cfff2d08d3a9	2025-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydrate 2	BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA	Natural Creations, Inc	1122605f-715e-4f12-9d9d-a20442f9cd45	2025-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3543a22c-34d5-e572-e063-6394a90ad579	2025-12-15		Exact identifier unii: 15FIX9V2JP
Stellar Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bb6488c-d216-8742-e063-6394a90a16e2	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bb8ee19-81b2-daed-e063-6394a90a0fb3	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bb6cfd4-fa4a-d1d9-e063-6394a90a8e43	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	35442ac0-c361-e08f-e063-6294a90a5cb2	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3543e85d-9bc7-b8ed-e063-6294a90ae7d3	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bc8593d-fc6c-04aa-e063-6394a90a6d56	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Mantra Wellness Spa	3389b0a3-40f9-b411-e063-6394a90a9959	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	39959db9-5ee1-a27c-e063-6394a90a1e10	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	3995f556-20fe-3e64-e063-6294a90a5efe	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	3995385b-b10b-ca5c-e063-6294a90af43f	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	3994aa84-30b4-3dc4-e063-6394a90a23e7	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	39947913-f1cc-25d2-e063-6294a90a4229	2025-12-15		Exact identifier unii: 15FIX9V2JP
Solar Shield Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DENISE BELL SKIN CARE	396eb781-5947-3665-e063-6294a90a38dd	2025-12-15		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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