pyrilamine maleate and dextromethorphan hydrobromide

Generic: pyrilamine maleate and dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name pyrilamine maleate and dextromethorphan hydrobromide
Generic Name pyrilamine maleate and dextromethorphan hydrobromide
Labeler westminster pharmaceuticals, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 7.5 mg/5mL, pyrilamine maleate 7.5 mg/5mL

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-398
Product ID 69367-398_c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

Pharmacologic Class

Classes
sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367398
Hyphenated Format 69367-398

Supplemental Identifiers

RxCUI
1423307
UNII
9D2RTI9KYH R35D29L3ZA

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 pyrilamine maleate and dextromethorphan hydrobromide (source: ndc)
Generic Name pyrilamine maleate and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (69367-398-16)
source: ndc

Packages (1)

69367-398-16 473 mL in 1 BOTTLE (69367-398-16)

Ingredients (2)

dextromethorphan hydrobromide (7.5 mg/5mL) pyrilamine maleate (7.5 mg/5mL)

Linked Drug Pages (1)

Pyrilamine Maleate and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4", "openfda": {"unii": ["9D2RTI9KYH", "R35D29L3ZA"], "rxcui": ["1423307"], "spl_set_id": ["dd068449-9d24-41e6-8a6e-f69c9fe263f2"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (69367-398-16)", "package_ndc": "69367-398-16", "marketing_start_date": "20240715"}], "brand_name": "Pyrilamine Maleate and Dextromethorphan Hydrobromide", "product_id": "69367-398_c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4", "dosage_form": "LIQUID", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "69367-398", "generic_name": "Pyrilamine Maleate and Dextromethorphan Hydrobromide", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pyrilamine Maleate and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "7.5 mg/5mL"}, {"name": "PYRILAMINE MALEATE", "strength": "7.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}