FDA.reportPublic FDA data

Alahist PE

Product NDC
50991-788
11-digit product format
509910788
Labeler code
50991
Product ID
50991-788_4513e2ae-4504-8fd3-e063-6394a90a7ff0
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Phenylephrine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-24
Substance
DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 7.5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alahist PE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBPA9UT29BS, 04JA59TNSJ
Rxcui2391334

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-788-02Alahist PE12 in 1 BLISTER PACKTABLET127
50991-788-90Alahist PE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-788-90EA - Each50991-788913cc3c9-be68-4c88-97b3-8b8798f5788d12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-788ALAHIST PE (DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [POLY PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20241111_ada2d582-5813-2029-e053-2a95a90ae567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2391334dexbrompheniramine maleate 2 MG / phenylephrine HCl 7.5 MG Oral TabletPSNada2d582-5813-2029-e053-2a95a90ae5677
2391334dexbrompheniramine maleate 2 MG / phenylephrine hydrochloride 7.5 MG Oral TabletSCDada2d582-5813-2029-e053-2a95a90ae5677
2391334dexbrompheniramine maleate 2 MG / phenylephrine HCl 7.5 MG Oral TabletSYada2d582-5813-2029-e053-2a95a90ae5677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50991-788-025099107880212 TABLET in 1 BLISTER PACK (50991-788-02) 12 tablet2020-08-240000-00-00NoNoCurrent
50991-788-905099107889090 TABLET in 1 BOTTLE (50991-788-90) 90 tablet2020-08-240000-00-00NoNoCurrent