duratuss dm

Generic: dexbrompheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name duratuss dm
Generic Name dexbrompheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride
Labeler poly pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dexbrompheniramine maleate 1 mg/5mL, dextromethorphan hydrobromide 10 mg/5mL, pseudoephedrine hydrochloride 30 mg/5mL

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-142
Product ID 50991-142_413a3951-d703-f14b-e063-6394a90a06dc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

Pharmacologic Class

Classes
adrenergic alpha-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-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991142
Hyphenated Format 50991-142

Supplemental Identifiers

RxCUI
2727430
UPC
0350991142167
UNII
BPA9UT29BS 9D2RTI9KYH 6V9V2RYJ8N

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 duratuss dm (source: ndc)
Generic Name dexbrompheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
  • 10 mg/5mL
  • 30 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (50991-142-16)
  • 20 mL in 1 BOTTLE (50991-142-20)
source: ndc

Packages (2)

50991-142-16 473 mL in 1 BOTTLE (50991-142-16) 50991-142-20 20 mL in 1 BOTTLE (50991-142-20)

Ingredients (3)

dexbrompheniramine maleate (1 mg/5mL) dextromethorphan hydrobromide (10 mg/5mL) pseudoephedrine hydrochloride (30 mg/5mL)

Linked Drug Pages (1)

DURATUSS DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "413a3951-d703-f14b-e063-6394a90a06dc", "openfda": {"upc": ["0350991142167"], "unii": ["BPA9UT29BS", "9D2RTI9KYH", "6V9V2RYJ8N"], "rxcui": ["2727430"], "spl_set_id": ["413a3951-d704-f14b-e063-6394a90a06dc"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (50991-142-16)", "package_ndc": "50991-142-16", "marketing_start_date": "20251015"}, {"sample": false, "description": "20 mL in 1 BOTTLE (50991-142-20)", "package_ndc": "50991-142-20", "marketing_start_date": "20251015"}], "brand_name": "DURATUSS DM", "product_id": "50991-142_413a3951-d703-f14b-e063-6394a90a06dc", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha-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-Adrenergic Agonist [EPC]"], "product_ndc": "50991-142", "generic_name": "Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DURATUSS", "brand_name_suffix": "DM", "active_ingredients": [{"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}