Topcare Nite Time Cold And Flu Tablet, Film Coated
NDC Package 76162-619-62

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

Package Information

Topcare Nite Time Cold And Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) tablets is •take only as directed – see overdose warning•do not exceed 8 caplets per 24 hrsadults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrsask a doctor children under 4 yrs do not use. This formulation utilizes a tablet, film coated delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-619 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76162-619-62
Package Description
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
76162-619
11-Digit Billing Format
76162061962

Clinical Specifications

Proprietary Name
Topcare Nite Time Cold And Flu
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•take only as directed – see overdose warning•do not exceed 8 caplets per 24 hrsadults & children 12 yrs & over 2 caplets with water every 4 hrschildren 4 to under 12 yrsask a doctor children under 4 yrs do 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
07-24-2026
Listing Expiration
12-31-2027
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 76162-619-62 identifies a specific commercial package of 12 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Topcare Nite Time Cold And Flu, a human over the counter drug labeled by Topco Associates Llc. This tablet, film coated 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 Topco Associates Llc on July 24, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162061962. 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)
76162-619-62
11-Digit CMS (5-4-2)
76162-0619-62

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