Vick’s Nyquil FDA compliance issues explained

[Dextromethorphan is an active ingredient in NyQuil. Image from raimund14/Adobe Stock]

Procter & Gamble (NYSE:PG) recently received a warning letter from FDA for failing to meet the agency’s requirements in the drug listing. The warning related to Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (National Drug Code (NDC): 58933-541), a powdered medicine intended to be dissolved in hot water before use.

The FDA’s drug listing process requires submitting information related to a drug product, including its name, active ingredients, dosage form, strength and labeling information. The agency asks that the information be submitted to its electronic Drug Registration and Listing System (eDRLS), an online application.

In its warning letter to Procter & Gamble, FDA noted that it sent a letter dated October 31, 2022 to the manufacturer with a list of deficiencies related to a type of Vicks Ny…

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