Cold Multi-symptom Daytime And Nighttime Kit
NDC Package 50804-551-02
Package Information
Cold Multi-symptom Daytime And Nighttime (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride) kits is do not take more than directed (see overdose warning) do not take Day and Night caplets at the same timedo not take more than a total of 12 caplets in 24 hoursadults and children 12 years and over take 2 caplets every 4 hoursswallow whole – do not crush, chew, or dissolvechildren under 12 years ask a doctor. This formulation utilizes a kit delivery system. Marketed by Goodsense, this product is identified by NDC 50804-551 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1086991 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet
- RxCUI: 1086991 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
- RxCUI: 1086991 - APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
- RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet
- RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50804 - Goodsense
- 50804-551 - Cold Multi-symptom Daytime And Nighttime
- 50804-551-02 - 1 KIT in 1 CARTON * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK
- 50804-551 - Cold Multi-symptom Daytime And Nighttime
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 50804-551-02 identifies a specific commercial package of 1 kit in 1 carton * 12 tablet, coated in 1 blister pack * 8 tablet, coated in 1 blister pack of Cold Multi-symptom Daytime And Nighttime, a human over the counter drug labeled by Goodsense. This kit is formulated for use and contains 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 Goodsense on December 31, 2011. The current certification is valid through December 31, 2026.
How is this Goodsense product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50804055102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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.