Health Data Standards and Terminologies A Tutorial

2: Terminology Standards and Tools


DailyMed


The DailyMed database reflects current drug label information that manufacturers/labelers provide to the FDA. Manufacturers submit labels in the form of Structured Product Labeling (SPL).

Series of three boxes: Manufacturer SPL goes to Approval by FDA goes to NLM DailyMed

Once NLM’s DailyMed team receives the SPL information from the FDA, it is presented in a user-friendly format on DailyMed which allows search by National Drug Code (NDC), SETID, or drug class. A SETID is a unique identifier for a group of similar SPLs. Each SPL also links to related RxNorm RXCUIs.

Each listed drug product is assigned an NDC, which is a unique 10-digit, 3-segment number. This number identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. The NDC can be found on the outside packaging of the drug. You can search with this number to find the exact drug you have. For example, the same drug may be produced by many different manufacturers, or the same drug may have different dosages. The NDC code would be unique for all of them and can help you distinguish between those result results.

Example NDC code on package (NDC 11822-0140-1):

NAPROXEN SODIUM package label showing NDC 11822-0140-1

Label on DailyMed (NAPROXEN SODIUM tablet, film coated):

Label information for NAPROXEN SODIUM tablet, film coated in DailyMed
Screenshot of DailyMed

Activity

Check any medication label you might have around your house, such as aspirin or acetaminophen. Try to identify the NDC on the package. Then search DailyMed using the same NDC.


References

"DailyMed - About." U.S. National Library of Medicine, National Institutes of Health, https://dailymed.nlm.nih.gov/dailymed/about-dailymed.cfm.

"DailyMed - Help." U.S. National Library of Medicine, National Institutes of Health, https://dailymed.nlm.nih.gov/dailymed/help.cfm.

"National Drug Code Database Background Information." U.S. Food and Drug Administration, Center for Drug Evaluation and Research, https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information.

"Structured Product Labeling Resources." U.S. Food and Drug Administration, Office of the Commissioner, https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources.