FDA.reportPublic FDA data

Alahist D

Product NDC
50991-776
11-digit product format
509910776
Labeler code
50991
Product ID
50991-776_4513de1e-86ae-0275-e063-6294a90a2c6a
Type
HUMAN OTC DRUG
Nonproprietary name
Pheniramine Maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-01
Substance
PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
17.5; 10 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 D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENIRAMINE MALEATE17.5 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNYW905655B, 04JA59TNSJ
Rxcui2286592, 2286598

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
50991-776-01Alahist D100 in 1 BOTTLETABLET1006
50991-776-02Alahist D12 in 1 BLISTER PACKTABLET126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-776-01EA - Each50991-7762f258a05-0c23-4d37-a5bf-609742e985d412020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-776ALAHIST D (PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240711_a1b8533a-ef8b-57cc-e053-2995a90a5d9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286598ALAHIST D 17.5 MG / 10 MG Oral TabletPSNa1b8533a-ef8b-57cc-e053-2995a90a5d9e6
2286592pheniramine maleate 17.5 MG / phenylephrine HCl 10 MG Oral TabletPSNa1b8533a-ef8b-57cc-e053-2995a90a5d9e6
2286598pheniramine maleate 17.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet [Alahist D]SBDa1b8533a-ef8b-57cc-e053-2995a90a5d9e6
2286592pheniramine maleate 17.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDa1b8533a-ef8b-57cc-e053-2995a90a5d9e6
2286598Alahist D (pheniramine maleate 17.5 MG / phenylephrine HCl 10 MG) Oral TabletSYa1b8533a-ef8b-57cc-e053-2995a90a5d9e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50991-776-0150991077601100 TABLET in 1 BOTTLE (50991-776-01) 100 tablet2020-04-010000-00-00NoNoCurrent
50991-776-025099107760212 TABLET in 1 BLISTER PACK (50991-776-02) 12 tablet2020-04-010000-00-00NoNoCurrent