rompe pecho nighttime

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name rompe pecho nighttime
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Labeler efficient laboratories inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, doxylamine succinate 12.5 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
EFFICIENT LABORATORIES INC

Identifiers & Regulatory

Product NDC 58593-830
Product ID 58593-830_3013da13-64a9-4800-e063-6294a90a6efe
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2019-09-01
Marketing End 2026-11-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] antihistamine [epc] histamine receptor antagonists [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 58593830
Hyphenated Format 58593-830

Supplemental Identifiers

RxCUI
1431245
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 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 rompe pecho nighttime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 12.5 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58593-830-06) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

58593-830-06 1 BOTTLE in 1 CARTON (58593-830-06) / 180 mL in 1 BOTTLE

Ingredients (4)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) doxylamine succinate (12.5 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Rompe Pecho Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3013da13-64a9-4800-e063-6294a90a6efe", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1431245"], "spl_set_id": ["2ec319a8-92bf-4552-86dd-37cbce18980f"], "manufacturer_name": ["EFFICIENT LABORATORIES INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58593-830-06)  / 180 mL in 1 BOTTLE", "package_ndc": "58593-830-06", "marketing_end_date": "20261130", "marketing_start_date": "20190901"}], "brand_name": "Rompe Pecho Nighttime", "product_id": "58593-830_3013da13-64a9-4800-e063-6294a90a6efe", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [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": "58593-830", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl", "labeler_name": "EFFICIENT LABORATORIES INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rompe Pecho", "brand_name_suffix": "Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261130", "marketing_start_date": "20190901"}