poly-hist dm

Generic: dextromethorphan hydrobromide, phenylephrine hcl and thonzylamine hcl

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

Drug Facts

Product Profile

Brand Name poly-hist dm
Generic Name dextromethorphan hydrobromide, phenylephrine hcl and thonzylamine hcl
Labeler poly pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, phenylephrine hydrochloride 5 mg/5mL, thonzylamine hydrochloride 25 mg/5mL

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-220
Product ID 50991-220_1cd9c2f2-67a8-3864-e063-6394a90a97fa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-06-22

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 50991220
Hyphenated Format 50991-220

Supplemental Identifiers

RxCUI
1427392
UNII
9D2RTI9KYH 04JA59TNSJ 6K9YKD48Y4

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-hist dm (source: ndc)
Generic Name dextromethorphan hydrobromide, phenylephrine hcl and thonzylamine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 5 mg/5mL
  • 25 mg/5mL
source: ndc
Packaging
  • 6 BOTTLE in 1 TRAY (50991-220-15) / 15 mL in 1 BOTTLE
  • 473 mL in 1 BOTTLE (50991-220-16)
source: ndc

Packages (2)

50991-220-15 6 BOTTLE in 1 TRAY (50991-220-15) / 15 mL in 1 BOTTLE 50991-220-16 473 mL in 1 BOTTLE (50991-220-16)

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) phenylephrine hydrochloride (5 mg/5mL) thonzylamine hydrochloride (25 mg/5mL)

Linked Drug Pages (1)

Poly-Hist DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1cd9c2f2-67a8-3864-e063-6394a90a97fa", "openfda": {"unii": ["9D2RTI9KYH", "04JA59TNSJ", "6K9YKD48Y4"], "rxcui": ["1427392"], "spl_set_id": ["d1c74d4c-71bb-4934-9a4e-556366c07fca"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE in 1 TRAY (50991-220-15)  / 15 mL in 1 BOTTLE", "package_ndc": "50991-220-15", "marketing_start_date": "20130622"}, {"sample": false, "description": "473 mL in 1 BOTTLE (50991-220-16)", "package_ndc": "50991-220-16", "marketing_start_date": "20130622"}], "brand_name": "Poly-Hist DM", "product_id": "50991-220_1cd9c2f2-67a8-3864-e063-6394a90a97fa", "dosage_form": "LIQUID", "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": "50991-220", "generic_name": "Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Poly-Hist DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}, {"name": "THONZYLAMINE HYDROCHLORIDE", "strength": "25 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130622", "listing_expiration_date": "20261231"}