Nite-timecold/flu Cherry Liquid
NDC Package 57243-502-25
Package Information
Nite-timecold/flu Cherry (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) liquids is take only as recommended-see Overdose warningsUse dose cup or tablespoon (TBSP)do not exceed 4 doses per 24 hoursadults & children 12 years and over 30 mL (2 TBSP) every 6 hourschildren 4 to under 12 years ask a doctorchildren under 4 years do not useIf taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours. This formulation utilizes a liquid delivery system. Marketed by Salado Sales, Inc., this product is identified by NDC 57243-502 and is authorized under FDA application M013.
Identification & Billing
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
- RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
- RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
- RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/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
- 57243 - Salado Sales, Inc.
- 57243-502 - Nite-timecold/flu Cherry
- 57243-502-25 - 177 mL in 1 BOTTLE
- 57243-502 - Nite-timecold/flu Cherry
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.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 57243-502-25 identifies a specific commercial package of 177 ml in 1 bottle of Nite-timecold/flu Cherry Cold/flu Cherry, a human over the counter drug labeled by Salado Sales, Inc.. This liquid is formulated for oral use and contains acetaminophen; 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 Salado Sales, Inc. on January 31, 2012. The current certification is valid through December 31, 2026.
How is this Salado Sales, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57243050225. 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.