# FDA drug labels

URL: https://docs.healthcare.dev/datasets/drug-labels

<Freshness dataset="dailymed-labels" />

|                 |                                                                                                                                                   |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------- |
| Source          | FDA labeling via NLM ([DailyMed](https://dailymed.nlm.nih.gov/dailymed/spl-resources-all-drug-labels.cfm)), human prescription labels             |
| Source id       | `nlm-dailymed`                                                                                                                                    |
| Release cadence | Daily (NLM's update files, Monday to Friday), rebuilt from the full release every 28 days                                                         |
| License         | No license or fee; credit "Courtesy of the U.S. National Library of Medicine" (in `meta.license_terms.attribution`)                               |
| Endpoints       | [`/v1/drugs/labels/{set_id}`](/reference/drugs/get-an-fda-drug-label), [`/v1/drugs/labels?ndc=&rxcui=&q=`](/reference/drugs/find-fda-drug-labels) |

Each record is the current version of one label (an SPL set id) with the products, package NDCs and
RxNorm concepts it covers, and four sections quoted from the label:

| Key                         | Section                   | LOINC   |
| --------------------------- | ------------------------- | ------- |
| `boxed_warning`             | Boxed warning             | 34066-1 |
| `indications_and_usage`     | Indications and usage     | 34067-9 |
| `dosage_and_administration` | Dosage and administration | 34068-7 |
| `contraindications`         | Contraindications         | 34070-3 |

Sections are plain text with the label's own wording: markup removed, paragraphs separated by blank
lines, list items one per line, table rows with cells separated by `|`, and subsection headings
(`2.1 Recommended Dose`) as their own paragraphs. Images are left out. A label without a section
(most have no boxed warning) simply doesn't list it. Every label carries `url`, its page on
DailyMed, to read the full label or cite it.

This is the FDA label text, not medical advice. Show it as the label's wording, with the label's
`effective_date` and the DailyMed link, rather than rephrasing it.

```sh
# Find the label for an NDC (any package of the product), then get its sections
curl "https://api.healthcare.dev/v1/drugs/labels?ndc=0003-0894-21" \
  -H "Authorization: Bearer $HDEV_API_KEY"

curl "https://api.healthcare.dev/v1/drugs/labels/e9481622-7cc6-418a-acb6-c5450daae9b0?sections=boxed_warning,contraindications" \
  -H "Authorization: Bearer $HDEV_API_KEY"
```

`GET /v1/drugs/ndc/{ndc}` links to the product's label as `links.label` when one lists it.

## Coverage and limits

- Human prescription labels only (DailyMed's "Rx" release). OTC, homeopathic, animal and other
  labels are not loaded.
- `rxcuis` come from NLM's SPL-RxNorm mapping file, refreshed with every release.
- `q` searches product names, labeler and title, not section text.
- A label removed from DailyMed is removed here with the next daily update; its earlier states stay
  in the change feed and history.