rynex dm

Generic: brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name rynex dm
Generic Name brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler edwards pharmaceuticals, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

brompheniramine maleate 1 mg/5mL, dextromethorphan hydrobromide 5 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Edwards Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 0485-0204
Product ID 0485-0204_4746cbef-775f-90ce-e063-6394a90a0781
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2011-03-14

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 04850204
Hyphenated Format 0485-0204

Supplemental Identifiers

RxCUI
1090463
UNII
IXA7C9ZN03 9D2RTI9KYH 04JA59TNSJ

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 rynex dm (source: ndc)
Generic Name brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
  • 5 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)
  • 473 mL in 1 BOTTLE (0485-0204-16)
source: ndc

Packages (2)

0485-0204-04 118 mL in 1 BOTTLE, PLASTIC (0485-0204-04) 0485-0204-16 473 mL in 1 BOTTLE (0485-0204-16)

Ingredients (3)

brompheniramine maleate (1 mg/5mL) dextromethorphan hydrobromide (5 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Rynex DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4746cbef-775f-90ce-e063-6394a90a0781", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1090463"], "spl_set_id": ["7be2c282-24ba-4f19-9b14-872d3f5746a7"], "manufacturer_name": ["Edwards Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)", "package_ndc": "0485-0204-04", "marketing_start_date": "20110314"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0485-0204-16)", "package_ndc": "0485-0204-16", "marketing_start_date": "20110314"}], "brand_name": "Rynex DM", "product_id": "0485-0204_4746cbef-775f-90ce-e063-6394a90a0781", "dosage_form": "LIQUID", "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": "0485-0204", "generic_name": "Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride", "labeler_name": "Edwards Pharmaceuticals, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rynex", "brand_name_suffix": "DM", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110314", "listing_expiration_date": "20271231"}