FDA – Drugs
Label and Content Review (OTC)
Fee: $349 / product
Labels of over-the-counter (OTC) drugs follow the "Drug Facts" format in 21 CFR 201.66. The sections appear in a fixed order, and the "Drug Facts" heading is set in a type size larger than the largest type used in the panel.
Who Is Obligated?
Manufacturers and labelers of OTC drugs to be sold in the United States.
What We Do
- We review the Drug Facts panel for content and format.
- We report missing sections and sections in the wrong order.
- We prepare the corrected English label text.
What You Receive
- Review report
- Corrected Drug Facts text
US Over-the-Counter (OTC) Drug Label Review Application
Product and active ingredient details for reviewing your OTC drug labels against the Drug Facts and monograph rules.
Frequently Asked Questions
- What is Drug Facts?
- It is the information panel required on the label of OTC drugs, with its sections presented in a fixed order.
- Are type sizes also regulated?
- Yes. For example, the "Drug Facts" heading is set in a type size larger than the largest type used in the panel. In the review we check the format as well as the content.
- Do you also prepare the English label text?
- Yes, we deliver the corrected Drug Facts text together with the review report.
Sources: 21 CFR 201.66.