Drugplain

Guaifenesin and Codeine Phosphate 10 mg/5mL

Guaifenesin and Codeine Phosphate · SOLUTION · Cardinal Health 107, LLC

3 Recalls on Record
Plain English

Guaifenesin and Codeine Phosphate is a solution containing guaifenesin and codeine phosphate at 10 mg/5mL, taken oral. Manufactured by Cardinal Health 107, LLC.

Key Facts

Brand Name
Guaifenesin and Codeine Phosphate
Generic Name
Guaifenesin and Codeine Phosphate
NDC Code (Product)
55154-5791
Manufacturer
Cardinal Health 107, LLC
Strength
10 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
DEA Schedule
Schedule V (Controlled)
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
06/27/2023

Recall History

3 Recalls on Record
Class III01/07/2025

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Superpotent; sodium benzoate preservative

CompletedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Guaifenesin and Codeine Phosphate used for?

Guaifenesin and Codeine Phosphate contains Guaifenesin and Codeine Phosphate. It is a solution taken oral. Consult your doctor for specific uses.

Is Guaifenesin and Codeine Phosphate a controlled substance?

Yes, Guaifenesin and Codeine Phosphate is classified as CV under the DEA Controlled Substances Act.

What is the generic name for Guaifenesin and Codeine Phosphate?

The generic name for Guaifenesin and Codeine Phosphate is Guaifenesin and Codeine Phosphate. There are no other listed brand versions of Guaifenesin and Codeine Phosphate.

What is the NDC code for Guaifenesin and Codeine Phosphate 10 mg/5mL?

The NDC (National Drug Code) for Guaifenesin and Codeine Phosphate 10 mg/5mL is 55154-5791, listed by Cardinal Health 107, LLC.

Product NDC

55154-5791

Package NDC

55154-5791-5

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)