Diurex

Product NDC: 52389-306
11-digit product format: 523890306
Labeler code: 52389
Product ID: 52389-306_32732994-0e5d-93a9-e063-6394a90a9c50
Type: HUMAN OTC DRUG
Nonproprietary name: Caffeine, magnesium salicylate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Kobayashi Healthcare International, Inc.
Application: M027
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-05-15
Substance: MAGNESIUM SALICYLATE; CAFFEINE
Active strength: 162.5; 50 mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52389-306	52389-306-21	D	Discontinued by firm		2026-10-12
excluded package	package	52389-306	52389-306-22	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	52389-306-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-306-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-306-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-306-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-306-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-306-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-306-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-306-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-306-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-306-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-306-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-306-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-306-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-306-22	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-306-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-306-22	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-306-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-306-22	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-306-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-306-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-306-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-306-22	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-306-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-306-22	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Diurex
Brand name suffix: Water Pills
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MAGNESIUM SALICYLATE	162.5 mg/1
CAFFEINE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
41728CY7UX	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1001437	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e02a39f9-1c8c-4d38-b394-3f5b7062932c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

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 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

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

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 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual Relief Maximum Strength	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	ARMY AND AIR FORCE EXCHANGE SERVICE	8282cb5a-6c38-4500-93bb-461e4d65df1c	2026-08-05	Warnings	Exact identifier application number: M027
Mantra Menstrual Pain Gel strawberry	ACETAMINOPHEN, PAMABROM	MOREMED INC.	22291ca3-04c0-4386-8001-aa9bb45d7f3b	2026-08-05	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Kroger Company	e97383af-6fbe-4531-af6a-c9ea9153e438	2026-08-03	Warnings	Exact identifier application number: M027
Midol Complete	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Select Consumer Group	3ca96ed9-d9af-dbfe-e063-6394a90a2932	2026-07-03	Warnings	Exact identifier application number: M027
MENSTRUAL COMPLETE	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Rite Aid Corporation	de723b85-011c-4014-82a8-e813460e3f12	2026-06-25	Warnings	Exact identifier application number: M027
Diurex Ultimate	CAFFEINE	Kobayashi Healthcare International, Inc.	c6debbfe-6061-463f-8f17-fb240c6f1bab	2026-06-08	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Topco Associates, LLC	62f03f3c-8475-40bd-a5e4-ec9292b74785	2026-05-19	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Meijer Distribution, Inc.	14dd377f-1d30-4991-ad29-5ed1058d4622	2026-05-18	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	H E B	cf228a60-4181-420f-8cb0-3db3d14a0f46	2026-05-18	Warnings	Exact identifier application number: M027
Menstrual Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Better Living Brands, LLC	d069487b-5856-4e3e-bc0e-5e57313c8231	2026-05-15	Warnings	Exact identifier application number: M027
Menstrual Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	CVS Pharmacy	289ec101-c9a3-45f1-b2cd-8eaf8e580130	2026-05-12	Warnings	Exact identifier application number: M027
PMS Relief Maximum Strength	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	CVS Pharmacy	760ee367-0625-48d7-98a7-84c69389ad3e	2026-05-12	Warnings	Exact identifier application number: M027
Multi-Symptom PMS Relief	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	81ef39e2-b91e-4d34-b594-4ba557cc319b	2026-05-11	Warnings	Exact identifier application number: M027
MENSTRUAL RELIEF	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	a44a5cf4-e88a-4da9-907a-8d8497c7d79d	2026-05-07	Warnings	Exact identifier application number: M027
Syncol Max	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Laboratorios Sanfer, S.A. de C.V.	c844d5c4-3e4b-4169-904e-eb5c3334bc4e	2026-04-20	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Family Dollar Services Inc	d9050ed0-455d-4903-8f30-3e9ec9a12886	2026-04-17	Warnings	Exact identifier application number: M027
Menstrual Pain Relief Maximum Strength / Multi Symptom	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	DOLGENCORP, LLC	d441088b-fb1d-4fdc-954f-032f3122212f	2026-04-08	Warnings	Exact identifier application number: M027
Menstrual Bloat Relief	PAMABROM	WALMART INC.	6479b326-8b20-401e-8224-a05f6d7dce2e	2026-04-07	Warnings	Exact identifier application number: M027
menstrual pain relief maximum strength	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Rite Aid Corporation	4a4ce4cd-1554-4772-a6f4-8f7830544949	2026-04-01	Warnings	Exact identifier application number: M027
Menstrual Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Geiss, Destin & Dunn Inc.	bf85fb32-66d4-4683-be9d-58ca4e9f272d	2026-02-06	Warnings	Exact identifier application number: M027

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
41728CY7UX	MAGNESIUM SALICYLATE	18917-95-8	MAGNESIUM SALICYLATE
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1001437	caffeine 50 MG / magnesium salicylate 162.5 MG Oral Tablet	PSN	e02a39f9-1c8c-4d38-b394-3f5b7062932c	13
1001437	caffeine 50 MG / magnesium salicylate 162.5 MG Oral Tablet	SCD	e02a39f9-1c8c-4d38-b394-3f5b7062932c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-306-01	52389030601	42 in 1 BLISTER PACK						Historical
52389-306-02	52389030602	11 in 1 BLISTER PACK						Historical
52389-306-21	52389030621	2 in 1 CARTON						Historical
52389-306-22	52389030622	2 in 1 CARTON						Historical
52389-306-36	52389030636	2 BLISTER PACK in 1 CARTON (52389-306-36) / 18 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2020-02-14	0000-00-00	No	No	Current
52389-306-42	52389030642	1 BLISTER PACK in 1 CARTON (52389-306-42) / 42 TABLET, COATED in 1 BLISTER PACK (52389-306-01)	1 blister pack	2005-05-15	0000-00-00	No	No	Current
52389-306-84	52389030684	2 BLISTER PACK in 1 CARTON (52389-306-84) / 42 TABLET, COATED in 1 BLISTER PACK (52389-306-01)	2 blister pack	2012-05-02	0000-00-00	No	No	Current