Theraflu Tablet, Chewable
NDC Package 0067-0112-01

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

Package Information

Theraflu (acetaminophen, diphenhydramine hcl) tablets is ▪do not use more than directed▪do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. This formulation utilizes a tablet, chewable delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-0112 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-0112-01
Package Description
20 TABLET, CHEWABLE in 1 BOTTLE
Product Code
0067-0112
11-Digit Billing Format
00067011201
RxNorm Crosswalk
  • RxCUI: 2691689 - acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Chewable Tablet
  • RxCUI: 2691689 - acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet
  • RxCUI: 2691689 - APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet

Clinical Specifications

Proprietary Name
Theraflu Severe Cold Relief Nighttime Soft Chews
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hcl
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
▪do not use more than directed▪do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist.AgeDoseadults and children 12 years of age and overtake 2 chewable tablets every 4 hourschildren under 12 years of agedo not use

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-30-2024
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 0067-0112-01 identifies a specific commercial package of 20 tablet, chewable in 1 bottle of Theraflu Severe Cold Relief Nighttime Soft Chews, a human over the counter drug labeled by Haleon Us Holdings Llc. This tablet, chewable is formulated for oral use and contains acetaminophen; diphenhydramine 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 September 30, 2024. 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: 00067011201. 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)
0067-0112-01
11-Digit CMS (5-4-2)
00067-0112-01

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