Diurex

Product NDC: 52389-325
11-digit product format: 523890325
Labeler code: 52389
Product ID: 52389-325_ec80e42c-e864-52e5-e053-2a95a90aaaf6
Type: HUMAN OTC DRUG
Nonproprietary name: Pamabrom
Dosage form: CAPSULE
Route: ORAL
Labeler: Alva-Amco Pharmacal Companies, Inc.
Application: M027
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2005-04-01
Marketing end: 0000-00-00
Substance: PAMABROM
Active strength: 50 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 product	product	52389-325		D	Discontinued by firm	2026-10-12
excluded package	package	52389-325	52389-325-21	D	Discontinued by firm	2026-10-12
excluded package	package	52389-325	52389-325-42	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 · 12 matching rows.

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

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

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pamabrom	ACTIVE INGREDIENT	UA8U0KJM72	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Pamabrom	ACTIVE MOIETY	UA8U0KJM72	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Citric acid	INACTIVE INGREDIENT	2968PHW8QP	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Magnesium oxide	INACTIVE INGREDIENT	3A3U0GI71G	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Povidone	INACTIVE INGREDIENT	FZ989GH94E	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Riboflavin	INACTIVE INGREDIENT	TLM2976OFR	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Shellac	INACTIVE INGREDIENT	46N107B71O	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Sucrose	INACTIVE INGREDIENT	C151H8M554	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-325	DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]	8	Legacy NDC	20240517_ab10451e-ff87-4974-bec4-7ba19c5bbe65.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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-325-21	52389032521	1 BLISTER PACK in 1 CARTON (52389-325-21) > 21 CAPSULE in 1 BLISTER PACK (52389-325-01)	1 blister pack	2005-04-01	0000-00-00	No	No	Current
52389-325-42	52389032542	2 BLISTER PACK in 1 CARTON (52389-325-42) > 21 CAPSULE in 1 BLISTER PACK (52389-325-01)	2 blister pack	2006-10-01	0000-00-00	No	No	Current