Night-time Liquid
NDC Package 53943-508-28
Package Information
Night-time (dextromethorphan hydrobromide, doxylamine succinate) liquids is use dose cup or tablespoon (TBSP)do not exceed 4 doses per 24 hoursWhen using Day Time and Night Time products, carefully read each label to ensure adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use. This formulation utilizes a liquid delivery system. Marketed by Discount Drug Mart, this product is identified by NDC 53943-508 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
- RxCUI: 1234386 - dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
- RxCUI: 1234386 - dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
- RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
Clinical Specifications
- 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)
Regulatory & Marketing
Hierarchy Structure
- 53943 - Discount Drug Mart
- 53943-508 - Night-time
- 53943-508-28 - 354 mL in 1 BOTTLE
- 53943-508 - Night-time
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 53943-508-28 identifies a specific commercial package of 354 ml in 1 bottle of Night-time Cough Relief, a human over the counter drug labeled by Discount Drug Mart. This liquid is formulated for oral use and contains dextromethorphan hydrobromide; doxylamine succinate 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 Discount Drug Mart on October 27, 2014. The current certification is valid through December 31, 2026.
How is this Discount Drug Mart product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 53943050828. 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.