histex-dm

Generic: dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride

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

Drug Facts

Product Profile

Brand Name histex-dm
Generic Name dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride
Labeler allegis pharmaceuticals, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/5mL, phenylephrine hydrochloride 10 mg/5mL, triprolidine hydrochloride 2.5 mg/5mL

Manufacturer
Allegis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 28595-804
Product ID 28595-804_0e764fe3-cd4a-71c8-e063-6394a90afa31
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-03-19

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 28595804
Hyphenated Format 28595-804

Supplemental Identifiers

RxCUI
1492052
UPC
0328595804163
UNII
9D2RTI9KYH 04JA59TNSJ 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 (source: ndc)
Generic Name dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
  • 10 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (28595-804-16)
source: ndc

Packages (1)

28595-804-16 473 mL in 1 BOTTLE (28595-804-16)

Ingredients (3)

dextromethorphan hydrobromide (20 mg/5mL) phenylephrine hydrochloride (10 mg/5mL) triprolidine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

HISTEX-DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e764fe3-cd4a-71c8-e063-6394a90afa31", "openfda": {"upc": ["0328595804163"], "unii": ["9D2RTI9KYH", "04JA59TNSJ", "YAN7R5L890"], "rxcui": ["1492052"], "spl_set_id": ["836d062c-29f0-4fd7-b65c-771a3bbd52c4"], "manufacturer_name": ["Allegis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (28595-804-16)", "package_ndc": "28595-804-16", "marketing_start_date": "20140319"}], "brand_name": "HISTEX-DM", "product_id": "28595-804_0e764fe3-cd4a-71c8-e063-6394a90afa31", "dosage_form": "SYRUP", "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": "28595-804", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE", "labeler_name": "Allegis Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HISTEX-DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}, {"name": "TRIPROLIDINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140319", "listing_expiration_date": "20261231"}