FDA.reportPublic FDA data

Ru-Hist D

Product NDC
28595-900
11-digit product format
285950900
Labeler code
28595
Product ID
28595-900_f0359ace-48e2-e8ec-e053-2a95a90afa85
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine Maleate and Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-01
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct28595-900DDiscontinued by firm2026-10-16
excluded packagepackage28595-90028595-900-60DDiscontinued by firm2026-10-16

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 · 4 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 packagepackage28595-900-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage28595-900-60f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
28595-900-602025-07-29C16284748780-13b156c62-299a-fb37-e063-e6dba90a4e07Ru-Hist D Tablet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-900-60EA - Each28595-900dbbb8c03-77df-445f-a7db-385121713ef212013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Brompheniramine MaleateACTIVE INGREDIENTIXA7C9ZN03RU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJRU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1
BrompheniramineACTIVE MOIETYH57G17P2FNRU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1
PhenylephrineACTIVE MOIETY1WS297W6MVRU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61URU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30RU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1
Sodium Starch Glycolate Type A CornINACTIVE INGREDIENTAG9B65PV6BRU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-900RU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]4Legacy NDC20240110_1a93fa51-94fb-434b-913f-b2424cf4d968.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
28595-900-602859509006060 TABLET, COATED in 1 BOTTLE (28595-900-60) 2013-11-010000-00-00NoNoCurrent