broncochem expectorant ii

Generic: acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl

Labeler: laboratorio magnachem international srl
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name broncochem expectorant ii
Generic Name acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl
Labeler laboratorio magnachem international srl
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/10mL, chlorpheniramine maleate 4 mg/10mL, dextromethorphan hydrobromide 13.33 mg/10mL, guaifenesin 200 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Identifiers & Regulatory

Product NDC 65131-116
Product ID 65131-116_383c518a-2d0c-4346-894c-9e089094d612
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part343
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 65131116
Hyphenated Format 65131-116

Supplemental Identifiers

RxCUI
1743369
UPC
0805418116875
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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 expectorant ii (source: ndc)
Generic Name acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl (source: ndc)
Application Number part343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/10mL
  • 4 mg/10mL
  • 13.33 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65131-116-87 1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (5)

acetaminophen (250 mg/10mL) chlorpheniramine maleate (4 mg/10mL) dextromethorphan hydrobromide (13.33 mg/10mL) guaifenesin (200 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

BRONCOCHEM EXPECTORANT II ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "383c518a-2d0c-4346-894c-9e089094d612", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0805418116875"], "unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1743369"], "spl_set_id": ["d0426469-9dd1-4bd1-b81e-69d33187daa2"], "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 (65131-116-87)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65131-116-87", "marketing_start_date": "20161230"}], "brand_name": "BRONCOCHEM EXPECTORANT II", "product_id": "65131-116_383c518a-2d0c-4346-894c-9e089094d612", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "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": "65131-116", "generic_name": "ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl", "labeler_name": "LABORATORIO MAGNACHEM INTERNATIONAL SRL", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BRONCOCHEM", "brand_name_suffix": "EXPECTORANT II", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/10mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "13.33 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "part343", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20161230", "listing_expiration_date": "20261231"}