FDA.reportPublic FDA data

Diurex

Product NDC
52389-136
11-digit product format
523890136
Labeler code
52389
Product ID
52389-136_b673291e-14b8-9b86-e053-2a95a90a8339
Type
HUMAN OTC DRUG
Nonproprietary name
Pamabrom
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Alva-Amco Pharmacal Companies, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2000-04-10
Marketing end
2022-01-31
Substance
PAMABROM
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52389-136DDiscontinued by firm2026-08-11
excluded packagepackage52389-13652389-136-20DDiscontinued by firm2026-08-11
excluded packagepackage52389-13652389-136-24DDiscontinued by firm2026-08-11
excluded packagepackage52389-13652389-136-40DDiscontinued by firm2026-08-11
excluded packagepackage52389-13652389-136-48DDiscontinued by firm2026-08-11

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52389-136-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52389-136-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52389-136-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52389-136-48d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52389-136-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52389-136-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52389-136-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52389-136-48f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52389-136-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52389-136-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52389-136-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52389-136-482ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52389-136-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52389-136-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52389-136-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52389-136-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52389-136-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52389-136-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52389-136-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52389-136-48cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52389-136-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52389-136-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52389-136-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52389-136-48cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52389-136-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52389-136-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52389-136-24302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52389-136-48302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52389-136-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52389-136-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52389-136-24ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52389-136-48ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52389-136-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52389-136-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52389-136-240efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52389-136-480efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52389-136-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52389-136-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52389-136-24ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52389-136-48ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52389-136-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52389-136-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52389-136-24367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52389-136-48367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52389-136-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52389-136-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52389-136-24557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52389-136-48557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PamabromACTIVE INGREDIENTUA8U0KJM72DIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
BROMOTHEOPHYLLINEACTIVE MOIETYFZG87K1MQ6DIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
GelatinINACTIVE INGREDIENT2G86QN327LDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Povidone K29/32INACTIVE INGREDIENT390RMW2PEQDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
SorbitolINACTIVE INGREDIENT506T60A25RDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RDIUREX (PAMABROM) CAPSULE, LIQUID FILLED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-136-20523890136201 BLISTER PACK in 1 CARTON (52389-136-20) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (52389-136-03) 1 blister pack2013-04-152022-01-31NoNoCurrent
52389-136-24523890136241 BLISTER PACK in 1 CARTON (52389-136-24) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-09-182022-01-31NoNoCurrent
52389-136-40523890136402 BLISTER PACK in 1 CARTON (52389-136-40) > 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-07-172022-01-31NoNoCurrent
52389-136-48523890136482 BLISTER PACK in 1 CARTON (52389-136-48) > 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-09-182022-01-31NoNoCurrent