polytussin dm

Generic: dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate

Labeler: poly pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name polytussin dm
Generic Name dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate
Labeler poly pharmaceuticals, inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 7.5 mg/5mL, phenylephrine hydrochloride 5 mg/5mL, pyrilamine maleate 12.5 mg/5mL

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-132
Product ID 50991-132_46518fef-1086-bff6-e063-6394a90a7e9f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-06-08

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991132
Hyphenated Format 50991-132

Supplemental Identifiers

RxCUI
2639753
UPC
0350991132168
UNII
9D2RTI9KYH 04JA59TNSJ R35D29L3ZA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name polytussin dm (source: ndc)
Generic Name dextromethorphan hbr, phenylephrine hcl, pyrilamine maleate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/5mL
  • 5 mg/5mL
  • 12.5 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (50991-132-15)
  • 480 mL in 1 BOTTLE (50991-132-16)
source: ndc

Packages (2)

50991-132-15 15 mL in 1 BOTTLE (50991-132-15) 50991-132-16 480 mL in 1 BOTTLE (50991-132-16)

Ingredients (3)

dextromethorphan hydrobromide (7.5 mg/5mL) phenylephrine hydrochloride (5 mg/5mL) pyrilamine maleate (12.5 mg/5mL)

Linked Drug Pages (1)

Polytussin DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46518fef-1086-bff6-e063-6394a90a7e9f", "openfda": {"upc": ["0350991132168"], "unii": ["9D2RTI9KYH", "04JA59TNSJ", "R35D29L3ZA"], "rxcui": ["2639753"], "spl_set_id": ["fda8f594-82bf-1781-e053-6294a90ad344"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (50991-132-15)", "package_ndc": "50991-132-15", "marketing_start_date": "20230608"}, {"sample": false, "description": "480 mL in 1 BOTTLE (50991-132-16)", "package_ndc": "50991-132-16", "marketing_start_date": "20230608"}], "brand_name": "Polytussin DM", "product_id": "50991-132_46518fef-1086-bff6-e063-6394a90a7e9f", "dosage_form": "SYRUP", "pharm_class": ["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]"], "product_ndc": "50991-132", "generic_name": "Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polytussin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "7.5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}, {"name": "PYRILAMINE MALEATE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230608", "listing_expiration_date": "20261231"}