poly-vent ir

Generic: 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 ir
Generic Name guaifenesin and pseudoephedrine hcl
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 380 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-212
Product ID 50991-212_26838be8-5a59-bb4d-e063-6394a90affe9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-06-11

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 50991212
Hyphenated Format 50991-212

Supplemental Identifiers

RxCUI
1426579
UNII
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 ir (source: ndc)
Generic Name guaifenesin and pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 380 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50991-212-01)
  • 12 TABLET in 1 BLISTER PACK (50991-212-02)
source: ndc

Packages (2)

50991-212-01 100 TABLET in 1 BOTTLE (50991-212-01) 50991-212-02 12 TABLET in 1 BLISTER PACK (50991-212-02)

Ingredients (2)

guaifenesin (380 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Poly-Vent IR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26838be8-5a59-bb4d-e063-6394a90affe9", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1426579"], "spl_set_id": ["ce0d8c45-446a-4df4-a36b-5000ba69d30d"], "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 (50991-212-01)", "package_ndc": "50991-212-01", "marketing_start_date": "20130611"}, {"sample": false, "description": "12 TABLET in 1 BLISTER PACK (50991-212-02)", "package_ndc": "50991-212-02", "marketing_start_date": "20130611"}], "brand_name": "Poly-Vent IR", "product_id": "50991-212_26838be8-5a59-bb4d-e063-6394a90affe9", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50991-212", "generic_name": "Guaifenesin and Pseudoephedrine HCl", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Poly-Vent IR", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "380 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130611", "listing_expiration_date": "20261231"}