Topcare Kit
NDC Package 76162-559-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Topcare (acetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr) kits is do not use more than directedtake every 6 hours, while symptoms persist. This formulation utilizes a kit delivery system. Marketed by Topco Associates, Llc, this product is identified by NDC 76162-559 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76162-559-12
Package Description
1 KIT in 1 CARTON * 6 POWDER in 1 CARTON (76162-539-06) * 6 POWDER in 1 CARTON (76162-549-06)
Product Code
11-Digit Billing Format
76162055912
RxNorm Crosswalk
  • RxCUI: 2636656 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution
  • RxCUI: 2636656 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution
  • RxCUI: 2636656 - APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution
  • RxCUI: 2636658 - acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral Solution
  • RxCUI: 2636658 - acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Topcare Multi Symptom Flu Relief Combo Pack
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Do not use more than directedtake every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not usedissolve contents of one packet into 8 oz. hot water; sip while hot. Consume the entire drink within 10-15 minutes.if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat. do not use more than directedtake every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not usedissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat

Regulatory & Marketing

Labeler Name
Topco Associates, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-16-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 76162-559-12 identifies a specific commercial package of 1 kit in 1 carton * 6 powder in 1 carton (76162-539-06) * 6 powder in 1 carton (76162-549-06) of Topcare Multi Symptom Flu Relief Combo Pack, a human over the counter drug labeled by Topco Associates, Llc. 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 Topco Associates, Llc on May 16, 2025. The current certification is valid through December 31, 2026.

How is this Topco Associates, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162055912. 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:

10-Digit Format (5-3-2)
76162-559-12
11-Digit CMS (5-4-2)
76162-0559-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.