rompe pecho cf

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: efficient laboratories inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name rompe pecho cf
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler efficient laboratories inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Efficient Laboratories Inc

Identifiers & Regulatory

Product NDC 58593-235
Product ID 58593-235_3e6375e6-6668-3453-e063-6394a90add02
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2007-10-01
Marketing End 2027-03-31

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 58593235
Hyphenated Format 58593-235

Supplemental Identifiers

RxCUI
1044949
UNII
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 rompe pecho cf (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 10 mL in 1 POUCH (58593-235-10)
source: ndc

Packages (1)

58593-235-10 10 mL in 1 POUCH (58593-235-10)

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Rompe Pecho CF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e6375e6-6668-3453-e063-6394a90add02", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1044949"], "spl_set_id": ["96c4dee1-6e66-4442-a7e3-56e874414c17"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Efficient Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 POUCH (58593-235-10)", "package_ndc": "58593-235-10", "marketing_end_date": "20270331", "marketing_start_date": "20190101"}], "brand_name": "Rompe Pecho CF", "product_id": "58593-235_3e6375e6-6668-3453-e063-6394a90add02", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "58593-235", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL", "labeler_name": "Efficient Laboratories Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rompe Pecho", "brand_name_suffix": "CF", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270331", "marketing_start_date": "20071001"}