FDA.reportPublic FDA data

ALAHIST DM

Product NDC
50991-444
11-digit product format
509910444
Labeler code
50991
Product ID
50991-444_4513dc1c-4884-da07-e063-6294a90a6450
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Pheniramine Maleate, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-08
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 12.5; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
PHENIRAMINE MALEATE12.5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, NYW905655B, 04JA59TNSJ
Rxcui2639752

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-444-15ALAHIST DM15 mL in 1 BOTTLELIQUID156
50991-444-16ALAHIST DM473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-444-16ML - Milliliter50991-444f6f7a2a1-78f3-4d19-8da5-14737258404d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-444ALAHIST DM (DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [POLY PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20241111_fdaa062d-110e-798d-e053-6394a90a755c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639752dextromethorphan HBr 10 MG / pheniramine maleate 12.5 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSNfdaa062d-110e-798d-e053-6394a90a755c6
2639752dextromethorphan hydrobromide 2 MG/ML / pheniramine maleate 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDfdaa062d-110e-798d-e053-6394a90a755c6
2639752dextromethorphan hydrobromide 10 MG / pheniramine maleate 12.5 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSYfdaa062d-110e-798d-e053-6394a90a755c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50991-444-155099104441515 mL in 1 BOTTLE (50991-444-15) 15 ml2023-06-08NoNoCurrent
50991-444-1650991044416473 mL in 1 BOTTLE (50991-444-16) 473 ml2023-06-08NoNoCurrent