rompe pechito dm for kids

Generic: dextromethorphan hbr, guaifenesin

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

Drug Facts

Product Profile

Brand Name rompe pechito dm for kids
Generic Name dextromethorphan hbr, guaifenesin
Labeler efficient laboratories inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/2.5mL, guaifenesin 50 mg/2.5mL

Manufacturer
Efficient Laboratories Inc

Identifiers & Regulatory

Product NDC 58593-276
Product ID 58593-276_411e99da-2482-40c7-e063-6394a90aaf80
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

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 58593276
Hyphenated Format 58593-276

Supplemental Identifiers

RxCUI
996520
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 rompe pechito dm for kids (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/2.5mL
  • 50 mg/2.5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (58593-276-04)
source: ndc

Packages (1)

58593-276-04 118 mL in 1 BOTTLE (58593-276-04)

Ingredients (2)

dextromethorphan hydrobromide (5 mg/2.5mL) guaifenesin (50 mg/2.5mL)

Linked Drug Pages (1)

Rompe Pechito DM for Kids ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "411e99da-2482-40c7-e063-6394a90aaf80", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["004d12e1-6e3d-84c8-e063-6394a90aa653"], "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 (58593-276-04)", "package_ndc": "58593-276-04", "marketing_start_date": "20230801"}], "brand_name": "Rompe Pechito DM for Kids", "product_id": "58593-276_411e99da-2482-40c7-e063-6394a90aaf80", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "58593-276", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Efficient Laboratories Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rompe Pechito", "brand_name_suffix": "DM for Kids", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/2.5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/2.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}