BroveX PSB

Product NDC
58605-150
11-digit product format
586050150
Labeler code
58605
Product ID
58605-150_79c81ee6-bae5-45b4-93c8-7b896a0975e3
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride and Brompheniramine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
MCR American Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-11-30
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
Active strength
20 mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct58605-150DDiscontinued by firm2026-10-05
excluded packagepackage58605-15058605-150-01DDiscontinued by firm2026-10-05
excluded packagepackage58605-15058605-150-02DDiscontinued by firm2026-10-05

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 · 39 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58605-150-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58605-150-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58605-150-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58605-150-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58605-150-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58605-150-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58605-150-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58605-150-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58605-150-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58605-150-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58605-150-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58605-150-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58605-150-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58605-150-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58605-150-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58605-150-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58605-150-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58605-150-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58605-150-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58605-150-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58605-150-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58605-150-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58605-150-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58605-150-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58605-150-02IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58605-150-01IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58605-150-012020-05-20BrōveX ™ PSB LIQUID
58605-150-022020-05-20BrōveX ™ PSB LIQUID
58605-150-012019-10-29BrōveX ™ PSB LIQUID
58605-150-022019-10-29BrōveX ™ PSB LIQUID

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-150-01ML - Milliliter58605-150820aea54-2dc6-4dce-ab2e-1fc85ab8df3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Brompheniramine MaleateACTIVE INGREDIENTIXA7C9ZN03BROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
BrompheniramineACTIVE MOIETYH57G17P2FNBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
Potassium CitrateINACTIVE INGREDIENTEE90ONI6FFBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4BROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4BROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RBROVEX PSB (PSEUDOEPHEDRINE HYDROCHLORIDE AND BROMPHENIRAMINE MALEATE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1