Rompe Pecho Liquid
NDC Package 58593-830-06
Package Information
Rompe Pecho (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl) liquids is Uses temporarily relieves these common cold/flu symtoms:minor aches and painsheadachenasal congestionsore throatrunny nose and sneezingcoughsinus congestion and pressurehelps clear nasal passagesrelieves cough to help you get to sleeptemporarily reduces fever. This formulation utilizes a liquid delivery system. Marketed by Efficient Laboratories Inc, this product is identified by NDC 58593-830 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1431245 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution
- RxCUI: 1431245 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
- RxCUI: 1431245 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
- RxCUI: 1431245 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
- RxCUI: 1431245 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 58593 - Efficient Laboratories Inc
- 58593-830 - Rompe Pecho
- 58593-830-06 - 1 BOTTLE in 1 CARTON / 180 mL in 1 BOTTLE
- 58593-830 - Rompe Pecho
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 58593-830-06 identifies a specific commercial package of 1 bottle in 1 carton / 180 ml in 1 bottle of Rompe Pecho Nighttime, a human over the counter drug labeled by Efficient Laboratories Inc. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate; phenylephrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Efficient Laboratories Inc on September 01, 2019.
How is this Efficient Laboratories Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 58593083006. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.