Can FDA DailyMed labels have errors?
Yes. FDA DailyMed publishes the labeling that companies submit to FDA as structured product labeling (SPL) files, and the National Library of Medicine, which runs it, states: "NLM does not review any SPL content prior to publication." SPL checks look at how the file is built, not whether every word is right, which is why correctly spelled wrong words can appear on live labels.
What DailyMed is
DailyMed is a public website that the National Library of Medicine (NLM), part of the National Institutes of Health, provides to the public. It holds labeling submitted to FDA by companies: prescribing information, patient labeling, carton and container labeling, over-the-counter Drug Facts labels and more. People use it to look up current label text.
What SPL is
SPL, or structured product labeling, is the electronic file format FDA uses for submitted labeling. It tags each part of the label, such as indications, warnings and directions, so systems can read and display it consistently.
Who checks what
In general terms:
- The company writes the label and is responsible for its content.
- SPL validation checks that the file meets FDA's technical rules for how it is built.
- The National Library of Medicine publishes the labeling. Its DailyMed page says the labeling there "may not have been verified by FDA" and that NLM does not review SPL content before publication.
None of those steps is a read-for-meaning pass on every word. If a wrong word is in the submission, it can be on the site.
Why correctly spelled wrong words survive
A contextual word error is a real word in the wrong slot. Spellcheck has nothing to flag, the sentence still parses, and the file is valid. So it rides through.
Three human-verified cases show it:
- An alcohol warning said "ever" where the limit needed "per". FDA DailyMed warning said "ever" instead of "per"
- A first-aid line on a wipe said "doctor" where it needed "water". FDA DailyMed wipe label said "doctor" instead of "water"
- A prescribing label's indications said "indicted" where it needed "indicated". FDA DailyMed label said "indicted" instead of "indicated"
Found an error? Who to tell
This is general information, not regulatory advice.
- The company first. The label lists who makes or distributes the product. They can correct the source.
- FDA, for a safety concern. If you think a label problem could hurt someone, FDA's MedWatch program takes voluntary reports from health professionals, patients and consumers, including reports of product use errors and quality problems.
DailyMed vs other sources
DailyMed shows the most recent labeling companies have submitted to FDA and say is in use. NLM notes that this may not be identical to the most recent FDA-approved labeling in FDA's Drugs@FDA database, or to the labeling packed with the product. When versions disagree, the company that owns the label is the one to ask.
FAQ
Can FDA DailyMed labels have errors?
Yes. DailyMed publishes labeling submitted to FDA by companies, and NLM does not review that content before publication, so a wrong word in the submission can appear on the site.
Does FDA or NLM review DailyMed text before it is posted?
NLM says it does not review SPL content before publication, and that DailyMed labeling may not have been verified by FDA. The company is responsible for its label's content.
Does SPL validation check spelling or meaning?
No. It checks the file against FDA's technical rules for how SPL is built, not whether the wording is right.
How do I report an error on a DailyMed label?
Contact the company listed on the label. For a safety concern, you can also report to FDA MedWatch.
Is the DailyMed label the official label?
It shows the most recent labeling submitted to FDA. NLM notes it may not be identical to the latest FDA-approved labeling or to the labeling packed with the product.