Cetafen Cough And Cold Tablet, Film Coated
NDC Package 50332-0141-7

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Cetafen Cough And Cold (acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, ,) tablets is usesTemporarily relieves these cold and flu symptomscoughsore throatheadacheminor aches and painsnasal congestionsinus congestion and pressurehelps loosen phlegm (mucus) and bronchial secretions to coughs more productiveTemporarily reduces fever. This formulation utilizes a tablet, film coated delivery system. Marketed by Hart Health, this product is identified by NDC 50332-0141 and is authorized under FDA application M.

Identification & Billing

NDC Package Code
50332-0141-7
Package Description
100 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET
Product Code
11-Digit Billing Format
50332014107
RxNorm Crosswalk
  • RxCUI: 1098435 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1098435 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1098435 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Cetafen Cough And Cold
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl , Guaifenesin, ,
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.
Usage Information
UsesTemporarily relieves these cold and flu symptomscoughsore throatheadacheminor aches and painsnasal congestionsinus congestion and pressurehelps loosen phlegm (mucus) and bronchial secretions to coughs more productiveTemporarily reduces fever

Regulatory & Marketing

Labeler Name
Hart Health
Product Type
Human Otc Drug
FDA Application #
M
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-09-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50332-0141). Click a package code to view its specific billing and regulatory data.

20 PACKET in 1 BAG / 2 TABLET, FILM COATED in 1 PACKET
40 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET

* 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 50332-0141-7 identifies a specific commercial package of 100 packet in 1 box / 2 tablet, film coated in 1 packet of Cetafen Cough And Cold, a human over the counter drug labeled by Hart Health. 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 Hart Health on January 09, 2023. The current certification is valid through December 31, 2026.

How is this Hart Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50332014107. 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)
50332-0141-7
11-Digit CMS (5-4-2)
50332-0141-07

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