Diurex

Product NDC: 52389-249
11-digit product format: 523890249
Labeler code: 52389
Product ID: 52389-249_3287c676-c9cc-273e-e063-6294a90a9c9b
Type: HUMAN OTC DRUG
Nonproprietary name: Pamabrom
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kobayashi Healthcare International, Inc.
Application: M027
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1995-12-20
Substance: PAMABROM
Active strength: 50 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	52389-249	52389-249-16	D	Discontinued by firm	2026-10-05
excluded package	package	52389-249	52389-249-20	D	Discontinued by firm	2026-10-05
excluded package	package	52389-249	52389-249-40	D	Discontinued by firm	2026-10-05

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 · 36 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	52389-249-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-249-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-249-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-249-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-249-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-249-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-249-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-249-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-249-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-249-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-249-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-249-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-249-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-249-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-249-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-249-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-249-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-249-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-249-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-249-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-249-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-249-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-249-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-249-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-249-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-249-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-249-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-249-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-249-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-249-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-249-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-249-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-249-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-249-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-249-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-249-16	`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: Max
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAMABROM	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UA8U0KJM72	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199158	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
37dfece3-d570-4ab2-ba95-af6eb1f3acd4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52389-249-10	DiurexMax	4 in 1 CARTON	TABLET, FILM COATED	4	14
52389-249-10	DiurexMax	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	14
52389-249-16	DiurexMax	2 in 1 CARTON	TABLET, FILM COATED	2	14
52389-249-16	DiurexMax	8 in 1 BLISTER PACK	TABLET, FILM COATED	8	14
52389-249-20	DiurexMax	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	14
52389-249-20	DiurexMax	1 in 1 CARTON	TABLET, FILM COATED	1	14
52389-249-24	DiurexMax	1 in 1 CARTON	TABLET, FILM COATED	1	14
52389-249-24	DiurexMax	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	14
52389-249-30	DiurexMax	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	14
52389-249-30	DiurexMax	3 in 1 CARTON	TABLET, FILM COATED	3	14
52389-249-40	DiurexMax	1 in 1 CARTON	TABLET, FILM COATED	1	14
52389-249-40	DiurexMax	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	14
52389-249-48	DiurexMax	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	14
52389-249-48	DiurexMax	2 in 1 CARTON	TABLET, FILM COATED	2	14
52389-249-50	DiurexMax	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	14
52389-249-50	DiurexMax	5 in 1 CARTON	TABLET, FILM COATED	5	14
52389-249-72	DiurexMax	3 in 1 CARTON	TABLET, FILM COATED	3	14
52389-249-72	DiurexMax	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pamabrom	ACTIVE INGREDIENT	UA8U0KJM72	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Pamabrom	ACTIVE MOIETY	UA8U0KJM72	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Calcium sulfate dihydrate	INACTIVE INGREDIENT	4846Q921YM	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Potassium gluconate	INACTIVE INGREDIENT	12H3K5QKN9	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Riboflavin	INACTIVE INGREDIENT	TLM2976OFR	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DIUREX MAX (PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]	2
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DIUREX MAX (PAMABROM) TABLET, FILM 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
52389-249	DIUREX MAX (PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	14	Current NDC, Legacy NDC, 18 package rows	20250413_37dfece3-d570-4ab2-ba95-af6eb1f3acd4.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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Discount Drug Mart	ba64c29d-4a50-47b7-be6b-6cf7db11a97a	2026-02-03	Warnings	Exact identifier application number: M027
Menstrual Relief	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	DOLGENCORP, LLC	89eb8196-54c6-4e30-8655-502cc4313c8a	2026-02-02	Warnings	Exact identifier application number: M027
Pamabrom	PAMABROM	Softgel Healthcare Pvt Ltd	186805ed-84fc-e723-e063-6294a90ad320	2026-01-27	Warnings	Exact identifier application number: M027
Menstrual Complete Pain Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Walgreen Company	210efe01-3cf4-404c-84b0-314615467ace	2026-01-20	Warnings	Exact identifier application number: M027
Menstrual Pain Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Walgreen Company	3916230c-39e5-4f64-aa0b-b090b000ec35	2026-01-20	Warnings	Exact identifier application number: M027
Menstrual Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Walgreen Company	fc258e1f-5447-421a-84a8-2d9e72fd6099	2026-01-20	Warnings	Exact identifier application number: M027
Thompson Cramp Relief	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Thompson Safety	e82f607d-05b1-2c50-e053-2995a90a607e	2026-01-08	Warnings	Exact identifier application number: M027
Menstrual Relief Maximum Strength	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Family Dollar Services Inc	e7e49ebb-4df4-420e-9b9d-74ee70754487	2026-01-07	Warnings	Exact identifier application number: M027
Pamprin Bloat	PAMABROM	Focus Consumer Healthcare, LLC	42f1846d-2d57-5221-e063-6394a90a3a9f	2025-12-31	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	WinCo Foods, LLC	860c4e94-1d1a-4f74-a14a-35f86f4523c4	2025-12-11	Warnings	Exact identifier application number: M027
Midol Bloat Relief	PAMABROM	Bayer HealthCare LLC.	c1ad6073-63f6-669f-e053-2995a90aacee	2025-12-04	Warnings	Exact identifier application number: M027
Midol Complete Caffeine Free	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Bayer HealthCare LLC.	177d78c7-871c-cb39-e063-6394a90aab24	2025-12-04	Warnings	Exact identifier application number: M027
Midol Complete Gelcaps	MIDOL COMPLETE	Bayer HealthCare LLC	0a4477ce-0a02-197d-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Chain Drug Marketing Association, Inc.	5f8f9644-48c5-4556-a0a4-7bdc9a629daa	2025-11-15	Warnings	Exact identifier application number: M027
Medi First Plus PMS Relief	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Unifirst First Aid Corporation	e84007e7-498d-4662-e053-2995a90ad4de	2025-09-09	Warnings	Exact identifier application number: M027
Green Guard Cramp Relief	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Unifirst First Aid Corporation	e6edff0f-94e4-7eba-e053-2a95a90a1d57	2025-09-08	Warnings	Exact identifier application number: M027
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	L.N.K. International, Inc.	c4a28f8f-030d-4487-b74f-13998482e72d	2025-08-18	Warnings	Exact identifier application number: M027
RIGHT REMEDIES Maximum Strength Diuretic	PAMABROM	Strive Pharmaceuticals Inc.	2d6492e0-1c16-6e3a-e063-6294a90a2440	2025-05-07	Warnings	Exact identifier application number: M027
Diurex Ultra	CAFFEINE	Kobayashi Healthcare International, Inc.	9a035265-40c6-43f5-8de6-6bece8449840	2025-04-14	Warnings	Exact identifier application number: M027
Diurex Max	PAMABROM	Kobayashi Healthcare International, Inc.	37dfece3-d570-4ab2-ba95-af6eb1f3acd4	2025-04-11	Warnings	Exact identifier application number: M027 ndc (product): 52389-249

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UA8U0KJM72	PAMABROM	606-04-2	PAMABROM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199158	pamabrom 50 MG Oral Tablet	PSN	37dfece3-d570-4ab2-ba95-af6eb1f3acd4	14
199158	pamabrom 50 MG Oral Tablet	SCD	37dfece3-d570-4ab2-ba95-af6eb1f3acd4	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-249-10	52389024910	4 BLISTER PACK in 1 CARTON (52389-249-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	2017-11-10	0000-00-00	No	No	Current
52389-249-16	52389024916	2 in 1 CARTON						Historical
52389-249-20	52389024920	30 in 1 BLISTER PACK						Historical
52389-249-24	52389024924	1 BLISTER PACK in 1 CARTON (52389-249-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2011-04-18	0000-00-00	No	No	Current
52389-249-30	52389024930	3 BLISTER PACK in 1 CARTON (52389-249-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2021-07-12	0000-00-00	No	No	Current
52389-249-40	52389024940	1 in 1 CARTON						Historical
52389-249-48	52389024948	2 BLISTER PACK in 1 CARTON (52389-249-48) / 24 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2013-07-18	0000-00-00	No	No	Current
52389-249-50	52389024950	5 BLISTER PACK in 1 CARTON (52389-249-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK	5 blister pack	2022-07-18	0000-00-00	No	No	Current
52389-249-72	52389024972	3 BLISTER PACK in 1 CARTON (52389-249-72) / 24 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2018-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diurex Max	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2025-04-11	HUMAN OTC DRUG LABEL	14