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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52389-406 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 52389-406 | 52389-406-18 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 52389-406 | 52389-406-22 | 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.
| 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 Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52389-406-01 | Diurex Water PillsXPL | 22 in 1 BLISTER PACK | TABLET, FILM COATED | 22 | 11 | |
| 52389-406-02 | Diurex Water PillsXPL | 18 in 1 BLISTER PACK | TABLET, FILM COATED | 18 | 11 | |
| 52389-406-18 | Diurex Water PillsXPL | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 11 | |
| 52389-406-22 | Diurex Water PillsXPL | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 11 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Midol Complete | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Bayer HealthCare LLC. | ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a324 | 2025-04-10 | Warnings | M027 |
| Diurex Water Pills | CAFFEINE, MAGNESIUM SALICYLATE | Kobayashi Healthcare International, Inc. | e02a39f9-1c8c-4d38-b394-3f5b7062932c | 2025-04-10 | Warnings | M027 |
| Cramp Tabs | ACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATE | JHK DBA American Safety & First Aid | c090807d-03b7-42d4-be41-f6240a3b330f | 2024-10-04 | Warnings | M027 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52389-406-01 | 52389040601 | 22 in 1 BLISTER PACK | Historical | |||||
| 52389-406-02 | 52389040602 | 18 in 1 BLISTER PACK | Historical | |||||
| 52389-406-18 | 52389040618 | 1 in 1 CARTON | Historical | |||||
| 52389-406-22 | 52389040622 | 1 BLISTER PACK in 1 CARTON (52389-406-22) > 22 TABLET, FILM COATED in 1 BLISTER PACK (52389-406-01) | 1 blister pack | 2016-08-17 | 0000-00-00 | No | No | Current |