broncochem maximum cough

Generic: dextromethorphan hbr-gyaifenesin

Labeler: laboratorio magnachem international srl
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name broncochem maximum cough
Generic Name dextromethorphan hbr-gyaifenesin
Labeler laboratorio magnachem international srl
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/10mL, guaifenesin 200 mg/10mL

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Identifiers & Regulatory

Product NDC 65131-091
Product ID 65131-091_b4e75d5f-2f1c-4ea0-84f2-705fd4631199
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2016-12-30

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65131091
Hyphenated Format 65131-091

Supplemental Identifiers

RxCUI
1234473
UPC
0805418091080
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 broncochem maximum cough (source: ndc)
Generic Name dextromethorphan hbr-gyaifenesin (source: ndc)
Application Number part341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/10mL
  • 200 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (65131-091-08) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65131-091-08 1 BOTTLE, PLASTIC in 1 BOX (65131-091-08) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (30 mg/10mL) guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

BRONCOCHEM MAXIMUM COUGH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4e75d5f-2f1c-4ea0-84f2-705fd4631199", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0805418091080"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1234473"], "spl_set_id": ["8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["LABORATORIO MAGNACHEM INTERNATIONAL SRL"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (65131-091-08)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65131-091-08", "marketing_start_date": "20161230"}], "brand_name": "BRONCOCHEM MAXIMUM COUGH", "product_id": "65131-091_b4e75d5f-2f1c-4ea0-84f2-705fd4631199", "dosage_form": "SYRUP", "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": "65131-091", "generic_name": "DEXTROMETHORPHAN HBr-GYAIFENESIN", "labeler_name": "LABORATORIO MAGNACHEM INTERNATIONAL SRL", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BRONCOCHEM", "brand_name_suffix": "MAXIMUM COUGH", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20161230", "listing_expiration_date": "20261231"}