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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52389-325DDiscontinued by firm2026-08-11
excluded packagepackage52389-32552389-325-21DDiscontinued by firm2026-08-11
excluded packagepackage52389-32552389-325-42DDiscontinued 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 · 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…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PamabromACTIVE INGREDIENTUA8U0KJM72DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PamabromACTIVE MOIETYUA8U0KJM72DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Citric acidINACTIVE INGREDIENT2968PHW8QPDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Magnesium oxideINACTIVE INGREDIENT3A3U0GI71GDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PovidoneINACTIVE INGREDIENTFZ989GH94EDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
RiboflavinINACTIVE INGREDIENTTLM2976OFRDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
ShellacINACTIVE INGREDIENT46N107B71ODIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
SucroseINACTIVE INGREDIENTC151H8M554DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
TalcINACTIVE INGREDIENT7SEV7J4R1UDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-325DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]8Legacy NDC20240517_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 1 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEARMY AND AIR FORCE EXCHANGE SERVICE8282cb5a-6c38-4500-93bb-461e4d65df1c2026-08-05WarningsExact identifier
application number: M027
Mantra Menstrual Pain Gel strawberryACETAMINOPHEN, PAMABROMMOREMED INC.22291ca3-04c0-4386-8001-aa9bb45d7f3b2026-08-05WarningsExact identifier
application number: M027
MEneraMENERATejeda Enterprises Incorporated471d53a3-f368-abdc-e063-6294a90a79582026-07-06WarningsExact identifier
application number: M027
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATESelect Consumer Group3ca96ed9-d9af-dbfe-e063-6394a90a29322026-07-03WarningsExact identifier
application number: M027
MENSTRUAL COMPLETEACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATERite Aid Corporationde723b85-011c-4014-82a8-e813460e3f122026-06-25WarningsExact identifier
application number: M027
Diurex UltimateCAFFEINEKobayashi Healthcare International, Inc.c6debbfe-6061-463f-8f17-fb240c6f1bab2026-06-08WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATETopco Associates, LLC62f03f3c-8475-40bd-a5e4-ec9292b747852026-05-19WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEMeijer Distribution, Inc.14dd377f-1d30-4991-ad29-5ed1058d46222026-05-18WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEH E Bcf228a60-4181-420f-8cb0-3db3d14a0f462026-05-18WarningsExact identifier
application number: M027
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEBetter Living Brands, LLCd069487b-5856-4e3e-bc0e-5e57313c82312026-05-15WarningsExact identifier
application number: M027
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECVS Pharmacy289ec101-c9a3-45f1-b2cd-8eaf8e5801302026-05-12WarningsExact identifier
application number: M027
PMS Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATECVS Pharmacy760ee367-0625-48d7-98a7-84c69389ad3e2026-05-12WarningsExact identifier
application number: M027
Multi-Symptom PMS ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED81ef39e2-b91e-4d34-b594-4ba557cc319b2026-05-11WarningsExact identifier
application number: M027
MENSTRUAL RELIEFACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa44a5cf4-e88a-4da9-907a-8d8497c7d79d2026-05-07WarningsExact identifier
application number: M027
Syncol MaxACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATELaboratorios Sanfer, S.A. de C.V.c844d5c4-3e4b-4169-904e-eb5c3334bc4e2026-04-20WarningsExact identifier
application number: M027
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEFamily Dollar Services Incd9050ed0-455d-4903-8f30-3e9ec9a128862026-04-17WarningsExact identifier
application number: M027
Menstrual Pain Relief Maximum Strength / Multi SymptomACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEDOLGENCORP, LLCd441088b-fb1d-4fdc-954f-032f3122212f2026-04-08WarningsExact identifier
application number: M027
Menstrual Bloat ReliefPAMABROMWALMART INC.6479b326-8b20-401e-8224-a05f6d7dce2e2026-04-07WarningsExact identifier
application number: M027
menstrual pain relief maximum strengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATERite Aid Corporation4a4ce4cd-1554-4772-a6f4-8f78305449492026-04-01WarningsExact identifier
application number: M027
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEGeiss, Destin & Dunn Inc.bf85fb32-66d4-4683-be9d-58ca4e9f272d2026-02-06WarningsExact identifier
application number: M027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-325-21523890325211 BLISTER PACK in 1 CARTON (52389-325-21) > 21 CAPSULE in 1 BLISTER PACK (52389-325-01) 1 blister pack2005-04-010000-00-00NoNoCurrent
52389-325-42523890325422 BLISTER PACK in 1 CARTON (52389-325-42) > 21 CAPSULE in 1 BLISTER PACK (52389-325-01) 2 blister pack2006-10-010000-00-00NoNoCurrent