FDA.reportPublic FDA data

Diurex Water Pills

Product NDC
52389-406
11-digit product format
523890406
Labeler code
52389
Product ID
52389-406_ec6cae02-5cd0-dea3-e053-2a95a90a49fb
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alva-Amco Pharmacal Companies, Inc.
Application
M027
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-08-17
Marketing end
0000-00-00
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
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52389-406DDiscontinued by firm2026-10-15
excluded packagepackage52389-40652389-406-18DDiscontinued by firm2026-10-15
excluded packagepackage52389-40652389-406-22DDiscontinued by firm2026-10-15

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-406-01Diurex Water PillsXPL22 in 1 BLISTER PACKTABLET, FILM COATED2211
52389-406-02Diurex Water PillsXPL18 in 1 BLISTER PACKTABLET, FILM COATED1811
52389-406-18Diurex Water PillsXPL1 in 1 CARTONTABLET, FILM COATED111
52389-406-22Diurex Water PillsXPL1 in 1 CARTONTABLET, FILM COATED111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-406DIUREX WATER PILLS XPL (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]10Legacy NDC, 4 package rows20240510_9f971b95-47f4-4bd4-beec-2296b4c9cbdc.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEDiscount Drug Martba64c29d-4a50-47b7-be6b-6cf7db11a97a2026-02-03WarningsExact identifier
application number: M027
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEDOLGENCORP, LLC89eb8196-54c6-4e30-8655-502cc4313c8a2026-02-02WarningsExact identifier
application number: M027
PamabromPAMABROMSoftgel Healthcare Pvt Ltd186805ed-84fc-e723-e063-6294a90ad3202026-01-27WarningsExact identifier
application number: M027
Menstrual Complete Pain ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Company210efe01-3cf4-404c-84b0-314615467ace2026-01-20WarningsExact identifier
application number: M027
Menstrual Pain ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Company3916230c-39e5-4f64-aa0b-b090b000ec352026-01-20WarningsExact identifier
application number: M027
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Companyfc258e1f-5447-421a-84a8-2d9e72fd60992026-01-20WarningsExact identifier
application number: M027
Thompson Cramp ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEThompson Safetye82f607d-05b1-2c50-e053-2995a90a607e2026-01-08WarningsExact identifier
application number: M027
Menstrual Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFamily Dollar Services Ince7e49ebb-4df4-420e-9b9d-74ee707544872026-01-07WarningsExact identifier
application number: M027
Pamprin BloatPAMABROMFocus Consumer Healthcare, LLC42f1846d-2d57-5221-e063-6394a90a3a9f2025-12-31WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWinCo Foods, LLC860c4e94-1d1a-4f74-a14a-35f86f4523c42025-12-11WarningsExact identifier
application number: M027
Midol Bloat ReliefPAMABROMBayer HealthCare LLC.c1ad6073-63f6-669f-e053-2995a90aacee2025-12-04WarningsExact identifier
application number: M027
Midol Complete Caffeine FreeACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.177d78c7-871c-cb39-e063-6394a90aab242025-12-04WarningsExact identifier
application number: M027
Midol Complete GelcapsMIDOL COMPLETEBayer HealthCare LLC0a4477ce-0a02-197d-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEChain Drug Marketing Association, Inc.5f8f9644-48c5-4556-a0a4-7bdc9a629daa2025-11-15WarningsExact identifier
application number: M027
Medi First Plus PMS ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEUnifirst First Aid Corporatione84007e7-498d-4662-e053-2995a90ad4de2025-09-09WarningsExact identifier
application number: M027
Green Guard Cramp ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEUnifirst First Aid Corporatione6edff0f-94e4-7eba-e053-2a95a90a1d572025-09-08WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEL.N.K. International, Inc.c4a28f8f-030d-4487-b74f-13998482e72d2025-08-18WarningsExact identifier
application number: M027
RIGHT REMEDIES Maximum Strength DiureticPAMABROMStrive Pharmaceuticals Inc.2d6492e0-1c16-6e3a-e063-6294a90a24402025-05-07WarningsExact identifier
application number: M027
Diurex UltraCAFFEINEKobayashi Healthcare International, Inc.9a035265-40c6-43f5-8de6-6bece84498402025-04-14WarningsExact identifier
application number: M027
Diurex MaxPAMABROMKobayashi Healthcare International, Inc.37dfece3-d570-4ab2-ba95-af6eb1f3acd42025-04-11WarningsExact identifier
application number: M027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-406-015238904060122 in 1 BLISTER PACKHistorical
52389-406-025238904060218 in 1 BLISTER PACKHistorical
52389-406-18523890406181 in 1 CARTONHistorical
52389-406-22523890406221 BLISTER PACK in 1 CARTON (52389-406-22) > 22 TABLET, FILM COATED in 1 BLISTER PACK (52389-406-01) 1 blister pack2016-08-170000-00-00NoNoCurrent