Leader Daytime Severe Cold And Flu Relief Tablet, Film Coated
NDC Package 70000-0636-1

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

Package Information

Leader Daytime Severe Cold And Flu Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) tablets is •take only as directed - see overdose warning•do not exceed 8 caplets per 24 hrsadults & children 12 yrs & over2 caplets with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use. This formulation utilizes a tablet, film coated delivery system. Marketed by Cardinal Health 110, Llc. Dba Leader, this product is identified by NDC 70000-0636 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
70000-0636-1
Package Description
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
70000-0636
11-Digit Billing Format
70000063601
RxNorm Crosswalk
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1110988 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Leader Daytime Severe Cold And Flu Relief
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
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 & over2 caplets with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

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
06-15-2023
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 70000-0636-1 identifies a specific commercial package of 12 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Leader Daytime Severe Cold And Flu Relief, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. This tablet, film coated is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride 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 June 15, 2023. The current certification is valid through December 31, 2026.

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: 70000063601. 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)
70000-0636-1
11-Digit CMS (5-4-2)
70000-0636-01

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