Topcare Daytime Nitetime Cold And Flu Relief Kit
NDC Package 76162-903-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Topcare Daytime Nitetime Cold And Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) kits is •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrs adults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use. This formulation utilizes a kit delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-903 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76162-903-02
Package Description
1 KIT in 1 CARTON * 355 mL in 1 BOTTLE (76162-599-40) * 355 mL in 1 BOTTLE (76162-483-40)
Product Code
76162-903
11-Digit Billing Format
76162090302
RxNorm Crosswalk
  • RxCUI: 1042675 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution
  • RxCUI: 1042675 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1042675 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1042675 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1042675 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Topcare Daytime Nitetime Cold And Flu Relief
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
•take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrs adults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-27-2025
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 76162-903-02 identifies a specific commercial package of 1 kit in 1 carton * 355 ml in 1 bottle (76162-599-40) * 355 ml in 1 bottle (76162-483-40) of Topcare Daytime Nitetime Cold And Flu Relief, 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 August 27, 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: 76162090302. 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)
76162-903-02
11-Digit CMS (5-4-2)
76162-0903-02

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