About drug product labeling
Drug manufacturers and distributors submit documentation about their products to FDA in the Structured Product Labeling (SPL) format. The labeling is a "living document" that changes over time to reflect increased knowledge about the safety and effectiveness of the drug.
The openFDA drug product labels API returns data from these submissions for both prescription and over-the-counter (OTC) drugs. The labels are broken into sections, such as indications for use (prescription drugs) or purpose (OTC drugs), adverse reactions, and so forth. There is considerable variation between drug products in terms of these sections and their contents, since the information required for safe and effective use varies with the unique characteristics of each drug product.
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How to search this endpoint
Make API calls to https://api.fda.gov/drug/label.json using search parameters for fields specific to the drug labeling endpoint.
Example API query
One drug product labeling record
This query searches for all records in a certain date range, and asks for a single one.
See the reference for more about effective_time. Brackets [ ] are used to specify a range for date, number, or string fields.
search for all records with effective_time between Jun 01, 2011 and Dec 31, 2012.
limit to 1 record.
Example API query
Product labeling record with a Boxed Warning
This query searches for labels with a Boxed Warning, and returns one result.
The _exists_ search modifier lets you search for records that contain a specific field, no matter what its contents are. See the API basics page for more details.
search for all records with a boxed_warning field.
limit to 1 record.
Example API query
Count of drug labeling, by product type
There are more labeling records for over-the-counter (OTC) drugs than prescription drugs.
The suffix .exact is required by openFDA to count the unique full phrases in the field openfda.product_type. Without it, the API will count each word in that field individually—HUMAN OTC DRUG would be counted as separate values, HUMAN and OTC and DRUG.
count the field openfda.product_type (product type).