cough dm

Generic: dextromethorphan polistirex

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cough dm
Generic Name dextromethorphan polistirex
Labeler major pharmaceuticals
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6312
Product ID 0904-6312_e5fb89d1-6bfa-4b05-9159-46483f132c40
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091135
Listing Expiration 2026-12-31
Marketing Start 2012-09-06

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 09046312
Hyphenated Format 0904-6312

Supplemental Identifiers

RxCUI
1373045
UNII
9D2RTI9KYH

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 cough dm (source: ndc)
Generic Name dextromethorphan polistirex (source: ndc)
Application Number ANDA091135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE
source: ndc

Packages (1)

0904-6312-56 1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (30 mg/5mL)

Linked Drug Pages (1)

cough dm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e5fb89d1-6bfa-4b05-9159-46483f132c40", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1373045"], "spl_set_id": ["cdb5616e-0f04-4b9e-a82b-994e9ba3b515"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6312-56)  / 89 mL in 1 BOTTLE", "package_ndc": "0904-6312-56", "marketing_start_date": "20120906"}], "brand_name": "cough dm", "product_id": "0904-6312_e5fb89d1-6bfa-4b05-9159-46483f132c40", "dosage_form": "SUSPENSION", "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": "0904-6312", "generic_name": "dextromethorphan polistirex", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "cough dm", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}], "application_number": "ANDA091135", "marketing_category": "ANDA", "marketing_start_date": "20120906", "listing_expiration_date": "20261231"}