Cold Relief Multi-symptom Kit
NDC Package 36800-250-56
Package Information
Cold Relief Multi-symptom (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 do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. This formulation utilizes a kit delivery system. Marketed by Topcare, this product is identified by NDC 36800-250 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
- 36800 - Topcare
- 36800-250 - Cold Relief Multi-symptom
- 36800-250-56 - 1 KIT in 1 CARTON * 12 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK
- 36800-250 - Cold Relief Multi-symptom
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 36800-250-56 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 Relief Multi-symptom, a human over the counter drug labeled by Topcare. 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 Topcare on October 01, 2011. The current certification is valid through December 31, 2026.
How is this Topcare product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800025056. 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.