Cetafen Cough And Cold Tablet, Film Coated
NDC Package 50332-0141-7
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
- 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
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 50332 - Hart Health
- 50332-0141 - Cetafen Cough And Cold
- 50332-0141-7 - 100 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET
- 50332-0141 - Cetafen Cough And Cold
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.
* 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.