histex-dm new formulation

Generic: dextromethorphan hbr, pseudoephedrine hci, and triprolidine hci

Labeler: allegis pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name histex-dm new formulation
Generic Name dextromethorphan hbr, pseudoephedrine hci, and triprolidine hci
Labeler allegis pharmaceuticals, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/5mL, pseudoephedrine hydrochloride 30 mg/5mL, triprolidine hydrochloride 2.5 mg/5mL

Manufacturer
Allegis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 28595-310
Product ID 28595-310_3001043a-7932-0867-e063-6294a90a91e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-03-10

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 28595310
Hyphenated Format 28595-310

Supplemental Identifiers

RxCUI
2707699
UNII
9D2RTI9KYH 6V9V2RYJ8N YAN7R5L890

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 histex-dm new formulation (source: ndc)
Generic Name dextromethorphan hbr, pseudoephedrine hci, and triprolidine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
  • 30 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (28595-310-16)
source: ndc

Packages (1)

28595-310-16 473 mL in 1 BOTTLE (28595-310-16)

Ingredients (3)

dextromethorphan hydrobromide (20 mg/5mL) pseudoephedrine hydrochloride (30 mg/5mL) triprolidine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

HISTEX-DM New Formulation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3001043a-7932-0867-e063-6294a90a91e6", "openfda": {"unii": ["9D2RTI9KYH", "6V9V2RYJ8N", "YAN7R5L890"], "rxcui": ["2707699"], "spl_set_id": ["30010401-e5b4-2bd9-e063-6394a90a0b0b"], "manufacturer_name": ["Allegis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (28595-310-16)", "package_ndc": "28595-310-16", "marketing_start_date": "20250310"}], "brand_name": "HISTEX-DM New Formulation", "product_id": "28595-310_3001043a-7932-0867-e063-6294a90a91e6", "dosage_form": "SYRUP", "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": "28595-310", "generic_name": "DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI", "labeler_name": "Allegis Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HISTEX-DM New Formulation", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/5mL"}, {"name": "TRIPROLIDINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250310", "listing_expiration_date": "20261231"}