rompe pecho ex

Generic: guaifenesin

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

Drug Facts

Product Profile

Brand Name rompe pecho ex
Generic Name guaifenesin
Labeler efficient laboratories inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

guaifenesin 200 mg/10mL

Manufacturer
Efficient Laboratories Inc

Identifiers & Regulatory

Product NDC 58593-829
Product ID 58593-829_26e4f72a-b911-8dc6-e063-6394a90a4326
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-01-01

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 58593829
Hyphenated Format 58593-829

Supplemental Identifiers

RxCUI
310604 1112205
UNII
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 rompe pecho ex (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/10mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (58593-829-04)
  • 178 mL in 1 BOTTLE (58593-829-06)
source: ndc

Packages (2)

58593-829-04 118 mL in 1 BOTTLE (58593-829-04) 58593-829-06 178 mL in 1 BOTTLE (58593-829-06)

Ingredients (1)

guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

Rompe Pecho EX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26e4f72a-b911-8dc6-e063-6394a90a4326", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310604", "1112205"], "spl_set_id": ["89ea23a5-0da7-407e-83d9-77a0b562f3af"], "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": "118 mL in 1 BOTTLE (58593-829-04)", "package_ndc": "58593-829-04", "marketing_start_date": "20190401"}, {"sample": false, "description": "178 mL in 1 BOTTLE (58593-829-06)", "package_ndc": "58593-829-06", "marketing_start_date": "20150101"}], "brand_name": "Rompe Pecho EX", "product_id": "58593-829_26e4f72a-b911-8dc6-e063-6394a90a4326", "dosage_form": "LIQUID", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "58593-829", "generic_name": "Guaifenesin", "labeler_name": "Efficient Laboratories Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rompe Pecho", "brand_name_suffix": "EX", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150101", "listing_expiration_date": "20261231"}