poly-vent dm

Generic: dextromethorphan hbr, guaifenesin and pseudoephedrine hcl

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

Drug Facts

Product Profile

Brand Name poly-vent dm
Generic Name dextromethorphan hbr, guaifenesin and pseudoephedrine hcl
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/1, guaifenesin 380 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-214
Product ID 50991-214_46518b53-5ca9-c68b-e063-6394a90a4150
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-06-17

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991214
Hyphenated Format 50991-214

Supplemental Identifiers

RxCUI
1427998
UNII
9D2RTI9KYH 495W7451VQ 6V9V2RYJ8N
NUI
N0000193956 N0000008867 N0000009560

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 poly-vent dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin and pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 380 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50991-214-01)
  • 12 POUCH in 1 CARTON (50991-214-02) / 1 TABLET in 1 POUCH
source: ndc

Packages (2)

50991-214-01 100 TABLET in 1 BOTTLE (50991-214-01) 50991-214-02 12 POUCH in 1 CARTON (50991-214-02) / 1 TABLET in 1 POUCH

Ingredients (3)

dextromethorphan hydrobromide (20 mg/1) guaifenesin (380 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Poly-Vent DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46518b53-5ca9-c68b-e063-6394a90a4150", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1427998"], "spl_set_id": ["739329ae-0b62-4eab-a07d-867b5d3d61e0"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50991-214-01)", "package_ndc": "50991-214-01", "marketing_start_date": "20130617"}, {"sample": false, "description": "12 POUCH in 1 CARTON (50991-214-02)  / 1 TABLET in 1 POUCH", "package_ndc": "50991-214-02", "marketing_start_date": "20130617"}], "brand_name": "Poly-Vent DM", "product_id": "50991-214_46518b53-5ca9-c68b-e063-6394a90a4150", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "50991-214", "generic_name": "Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Poly-Vent DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "380 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130617", "listing_expiration_date": "20261231"}