Childrens Cough And Cold Liquid
NDC Package 55319-754-04
Package Information
Childrens Cough And Cold (chlorpheniramine maleate, dextrometrorphan hbr) liquids is ▪measure only with dosing cup provided▪keep dosing cup with product▪mL = milliliter▪do not take more than 4 doses in any 24-hour periodagedoseChildren under 6 yearsdo not usechildren 6 to under 12 years10 mL every 6 hoursadults and children 12 years and older20 mL every 6 hours. This formulation utilizes a liquid delivery system. Marketed by Family Dollar Services Inc, this product is identified by NDC 55319-754 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1111440 - chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution
- RxCUI: 1111440 - chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution
- RxCUI: 1111440 - chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution
- RxCUI: 1111440 - chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution
Clinical Specifications
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- 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)
Regulatory & Marketing
Hierarchy Structure
- 55319 - Family Dollar Services Inc
- 55319-754 - Childrens Cough And Cold
- 55319-754-04 - 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
- 55319-754 - Childrens Cough And Cold
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 55319-754-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Cough And Cold, a human over the counter drug labeled by Family Dollar Services Inc. This liquid is formulated for oral use and contains chlorpheniramine maleate; dextromethorphan hydrobromide 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 Family Dollar Services Inc on May 08, 2023. The current certification is valid through December 31, 2026.
How is this Family Dollar Services Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 55319075404. 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.