durahist

Generic: dexbrompheniramine maleate, pseudoephedrine hcl

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

Drug Facts

Product Profile

Brand Name durahist
Generic Name dexbrompheniramine maleate, pseudoephedrine hcl
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexbrompheniramine maleate 2 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-865
Product ID 50991-865_472deea6-1315-b265-e063-6394a90a0e34
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-04-22

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991865
Hyphenated Format 50991-865

Supplemental Identifiers

RxCUI
1363513
UPC
0350991865905
UNII
BPA9UT29BS 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 durahist (source: ndc)
Generic Name dexbrompheniramine maleate, pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BLISTER PACK (50991-865-02)
  • 90 TABLET in 1 BOTTLE, PLASTIC (50991-865-90)
source: ndc

Packages (2)

50991-865-02 12 TABLET in 1 BLISTER PACK (50991-865-02) 50991-865-90 90 TABLET in 1 BOTTLE, PLASTIC (50991-865-90)

Ingredients (2)

dexbrompheniramine maleate (2 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Durahist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "472deea6-1315-b265-e063-6394a90a0e34", "openfda": {"upc": ["0350991865905"], "unii": ["BPA9UT29BS", "6V9V2RYJ8N"], "rxcui": ["1363513"], "spl_set_id": ["33d71863-5cac-669f-e063-6394a90a6f21"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BLISTER PACK (50991-865-02)", "package_ndc": "50991-865-02", "marketing_start_date": "20251229"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (50991-865-90)", "package_ndc": "50991-865-90", "marketing_start_date": "20250422"}], "brand_name": "Durahist", "product_id": "50991-865_472deea6-1315-b265-e063-6394a90a0e34", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50991-865", "generic_name": "Dexbrompheniramine Maleate, Pseudoephedrine HCL", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Durahist", "active_ingredients": [{"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "2 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250422", "listing_expiration_date": "20261231"}