Leader Powder, For Solution
NDC Package 70000-0764-1

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

Package Information

Leader (acetaminophen, dextromethorphan hbr) powders is •do not use more than directed•take every 6 hours, while symptoms persist•do not take more than 3 packets in 24 hours unless directed by a doctor  Age Dose adults and children 12 years of age and over One packet children under 12 years of age do not use▪dissolve contents of one packet into 8 oz. This formulation utilizes a powder, for solution delivery system. Marketed by Cardinal Health 110, Llc. Dba Leader, this product is identified by NDC 70000-0764 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
70000-0764-1
Package Description
6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET
Product Code
70000-0764
11-Digit Billing Format
70000076401

Clinical Specifications

Proprietary Name
Leader Multi Symptom Flu Relief Daytime Max Strength
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not use more than directed•take every 6 hours, while symptoms persist•do not take more than 3 packets in 24 hours unless directed by a doctor  Age Dose adults and children 12 years of age and over One packet children under 12 years of age do not use▪dissolve 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: sip briskly before and after heating.▪do not overheat.

Regulatory & Marketing

Labeler Name
Cardinal Health 110, Llc. Dba Leader
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2026
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 70000-0764-1 identifies a specific commercial package of 6 packet in 1 carton / 1 powder, for solution in 1 packet of Leader Multi Symptom Flu Relief Daytime Max Strength, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. This powder, for solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide 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 Cardinal Health 110, Llc. Dba Leader on July 01, 2026. The current certification is valid through December 31, 2027.

How is this Cardinal Health 110, Llc. Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000076401. 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 (5-4-1)
70000-0764-1
11-Digit CMS (5-4-2)
70000-0764-01

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