Panadol Tablet, Film Coated
NDC Package 0135-0607-03

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

Package Information

Panadol (acetaminophen and phenyleprine hcl) tablets is •do not take more than directed (see overdose warning)•adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist or as directed by a doctor•do not take more than 12 caplets in 24 hours, unless directed by a doctor•children under 12 years of age: ask a doctor•swallow whole – do not crush, chew or dissolve. This formulation utilizes a tablet, film coated delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0135-0607 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
0135-0607-03
Package Description
50 PACKET in 1 CARTON / 2 TABLET, FILM COATED in 1 PACKET (0135-0607-01)
Product Code
0135-0607
11-Digit Billing Format
00135060703
RxNorm Crosswalk
  • RxCUI: 1046378 - acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1046378 - acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1046378 - APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Panadol Cold And Flu Nondrowsy
Non-Proprietary Name
Acetaminophen And Phenyleprine Hcl
Substance Name
Acetaminophen; 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
•do not take more than directed (see overdose warning)•adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist or as directed by a doctor•do not take more than 12 caplets in 24 hours, unless directed by a doctor•children under 12 years of age: ask a doctor•swallow whole – do not crush, chew or dissolve

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0135-0607). Click a package code to view its specific billing and regulatory data.

0135-0607-02
3 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK

* 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 0135-0607-03 identifies a specific commercial package of 50 packet in 1 carton / 2 tablet, film coated in 1 packet (0135-0607-01) of Panadol Cold And Flu Nondrowsy, a human over the counter drug labeled by Haleon Us Holdings Llc. This tablet, film coated is formulated for oral use and contains acetaminophen; 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 Haleon Us Holdings Llc on June 01, 2017. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00135060703. 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 (4-4-2)
0135-0607-03
11-Digit CMS (5-4-2)
00135-0607-03

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