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 33 of 191 · 3,820 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6b27df44-c441-4ae8-a1b0-a9cf2fff6f21	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3c295f6b-6202-a2e1-e063-6394a90a9a60	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	b2eee48f-b644-403c-a57e-04a1491bc386	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	ebcc2c6c-a039-48d5-8c1c-5b347254c4c2	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6967f8bc-3092-44a9-926a-6c11676425e5	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	37d4d8c1-e76b-48a3-9a13-f0543af1b28f	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	fa5046f2-a6db-4ac3-a78f-1b5df075d7e8	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	0c5fc63f-1899-4406-944a-1cdcdf8b4277	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	58a84ecd-3f27-40fc-8e0b-e29192679e6b	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
BioMicroneedle PDRN Cream	SILICON DIOXIDE	Guangzhou Shengyanghui Industrial Trading Co., Ltd	48e2edae-94ea-c42e-e063-6394a90a907b	2026-01-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg	ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG	Farmacias De Similares TX LLC	48ea0a2c-511b-4805-e063-6394a90a1225	2026-01-21	Warnings	Exact identifier unii: 3G6A5W338E
sunscreen	TITANIUM DIOXIDE	Guangdong Zhoubang Biotechnology Co., Ltd	48f13b1c-8104-881b-e063-6394a90a816d	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
Awake Maximum Strength	CAFFEINE	Better Living Brands, LLC	ce4da457-805f-4d2a-8667-6516eea85221	2026-01-21	Warnings	Exact identifier unii: 3G6A5W338E
Inflammation I	ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA	BioActive Nutritional, Inc.	3cb12181-ae7e-45c7-a1b1-e1952f36f8c3	2026-01-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Menstrual Complete Pain Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Walgreen Company	210efe01-3cf4-404c-84b0-314615467ace	2026-01-20	Warnings	Exact identifier application number: M027 unii: 3G6A5W338E
Menstrual Pain Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Walgreen Company	3916230c-39e5-4f64-aa0b-b090b000ec35	2026-01-20	Warnings	Exact identifier application number: M027 unii: 3G6A5W338E
Assorted Fruit Antacid Flavor Chews	CALCIUM CARBONATE	Walmart	77ce0a54-6656-37b1-e053-2991aa0a334a	2026-01-20	Warnings	Exact identifier unii: H0G9379FGK
Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Welmedix LLC	48da4589-0f5a-c25b-e063-6394a90ac18b	2026-01-20	Warnings	Exact identifier unii: 15FIX9V2JP
KONEUK SUNSCREEN SPF50	KONEUK SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	48dd7f6e-2a4d-2c92-e063-6294a90a4255	2026-01-20	Warnings	Exact identifier unii: 15FIX9V2JP
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Meijer Distribution Inc	6e8ed233-9ffb-46f7-9632-d5bc3d3a558b	2026-01-20	Warnings	Exact identifier unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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