Diurex

Product NDC: 52389-155
11-digit product format: 523890155
Labeler code: 52389
Product ID: 52389-155_32c05c2a-5010-0362-e063-6394a90af7cf
Type: HUMAN OTC DRUG
Nonproprietary name: Caffeine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kobayashi Healthcare International, Inc.
Application: M027
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-09-01
Substance: CAFFEINE
Active strength: 100 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAFFEINE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
308853	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
9a035265-40c6-43f5-8de6-6bece8449840	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
52389-155-02	DiurexUltra	80 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	80	15
52389-155-02	DiurexUltra	2 in 1 PACKAGE	TABLET, FILM COATED	2	15
52389-155-80	DiurexUltra	80 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	80	15
52389-155-90	DiurexUltra	1 in 1 CARTON	TABLET, FILM COATED	1	15
52389-155-90	DiurexUltra	90 in 1 BOTTLE	TABLET, FILM COATED	90	15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Caffeine	ACTIVE INGREDIENT	3G6A5W338E	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Caffeine	ACTIVE MOIETY	3G6A5W338E	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Acacia	INACTIVE INGREDIENT	5C5403N26O	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Ethyl vanillin	INACTIVE INGREDIENT	YC9ST449YJ	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Magnesium silicate	INACTIVE INGREDIENT	9B9691B2N9	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polyethylene glycol 600	INACTIVE INGREDIENT	NL4J9F21N9	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-155	DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	15	Current NDC, Legacy NDC, 5 package rows	20250416_9a035265-40c6-43f5-8de6-6bece8449840.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 · 49 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
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308853	caffeine 100 MG Oral Tablet	PSN	9a035265-40c6-43f5-8de6-6bece8449840	15
308853	caffeine 100 MG Oral Tablet	SCD	9a035265-40c6-43f5-8de6-6bece8449840	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-155-02	52389015502	2 BOTTLE, PLASTIC in 1 PACKAGE (52389-155-02) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-01-04		No	No	Current
52389-155-80	52389015580	80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-155-80)		2005-09-01	0000-00-00	No	No	Current
52389-155-90	52389015590	1 BOTTLE in 1 CARTON (52389-155-90) / 90 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2005-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diurex Ultra	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2025-04-14	HUMAN OTC DRUG LABEL	15