Mucus Relief Solution
NDC Package 76162-057-88
Package Information
Mucus Relief (dextromethorphan hbr, guaifenesin, phenylephrine hcl) solution is do not take more than directeddo not take more than 6 doses in any 24-hour periodmL = milliliteronly use the dose cup provideddose as follows or as directed by a doctorAge Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 5 mL every 4 hours children under 4 years do not use. This formulation utilizes a solution delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-057 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1043543 - dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
- RxCUI: 1043543 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
- RxCUI: 1043543 - dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
- RxCUI: 1043543 - dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- 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
- 76162 - Topco Associates Llc
- 76162-057 - Mucus Relief
- 76162-057-88 - 1 BOTTLE, PLASTIC in 1 CARTON / 201 mL in 1 BOTTLE, PLASTIC
- 76162-057 - Mucus Relief
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 76162-057-88 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 201 ml in 1 bottle, plastic of Mucus Relief Childrens, a human over the counter drug labeled by Topco Associates Llc. This solution is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin; 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 Topco Associates Llc on March 07, 2024. The current certification is valid through December 31, 2027.
How is this Topco Associates Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162005788. 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.