FDA.reportPublic FDA data

Polytussin DM

Product NDC
50991-132
11-digit product format
509910132
Labeler code
50991
Product ID
50991-132_46518fef-1086-bff6-e063-6394a90a7e9f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate
Dosage form
SYRUP
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-08
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength
7.5; 5; 12.5 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
Polytussin DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL
PYRILAMINE MALEATE12.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 04JA59TNSJ, R35D29L3ZA
Rxcui2639753

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50991-132-152025-12-09C16284748780-13b156c62-2951-fb37-e063-e6dba90a4e07Polytussin DM
50991-132-162025-12-09C16284748780-13b156c62-2951-fb37-e063-e6dba90a4e07Polytussin DM
50991-132-152025-07-29C16284748780-13b156c62-2951-fb37-e063-e6dba90a4e07Polytussin DM
50991-132-162025-07-29C16284748780-13b156c62-2951-fb37-e063-e6dba90a4e07Polytussin DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-132-15Polytussin DM15 mL in 1 BOTTLESYRUP156
50991-132-16Polytussin DM480 mL in 1 BOTTLESYRUP4806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-132-16ML - Milliliter50991-132d5683f16-5ffc-4d62-a4dc-fe97d132025012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-132POLYTUSSIN DM (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE) SYRUP [POLY PHARMACEUTICALS, INC.]4Current NDC, 2 package rows20241109_fda8f594-82bf-1781-e053-6294a90ad344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639753dextromethorphan HBr 7.5 MG / phenylephrine HCl 5 MG / pyrilamine maleate 12.5 MG in 5 mL Oral SolutionPSNfda8f594-82bf-1781-e053-6294a90ad3446
2639753dextromethorphan hydrobromide 1.5 MG/ML / phenylephrine hydrochloride 1 MG/ML / pyrilamine maleate 2.5 MG/ML Oral SolutionSCDfda8f594-82bf-1781-e053-6294a90ad3446
2639753dextromethorphan hydrobromide 7.5 MG / phenylephrine hydrochloride 5 MG / pyrilamine maleate 12.5 MG per 5 ML Oral SolutionSYfda8f594-82bf-1781-e053-6294a90ad3446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50991-132-155099101321515 mL in 1 BOTTLE (50991-132-15) 15 ml2023-06-08NoNoCurrent
50991-132-1650991013216480 mL in 1 BOTTLE (50991-132-16) 480 ml2023-06-08NoNoCurrent