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FDA Labels Search API

Search FDA drug labels (SPL) with full-text search and filtering.

Endpoint

GET /v1/fda-label/search

Quick Start

Node.js
import { Fhirfly } from "@fhirfly-io/terminology";

const client = new Fhirfly({ apiKey: "YOUR_API_KEY" });

// Search for acetaminophen labels
const results = await client.fdaLabel.search({
  q: "acetaminophen"
});

console.log(`Found ${results.total} labels`);
for (const item of results.items) {
  console.log(`${item.name} (${item.product_type})`);
}

Parameters

Text Search

Parameter Description Example
q General text search across all fields q=tylenol
name Search by product name name=acetaminophen
brand Search by brand name brand=tylenol
generic Search by generic name generic=acetaminophen
substance Search by active ingredient substance=ibuprofen
manufacturer Search by manufacturer name manufacturer=johnson

Filters

Parameter Type Description Example
product_type string OTC, prescription, or cellular otc, rx, cellular
route string Administration route oral, topical, intravenous
pharm_class string Pharmacologic class Nonsteroidal Anti-inflammatory
rxcui string RxNorm concept ID rxcui=313782
ndc string National Drug Code ndc=0363-0225
application_number string FDA application number application_number=NDA020503
has_rxcui boolean Has linked RxNorm codes true, false
is_current boolean Current labels only (default: true) true, false

Pagination & Response

Parameter Default Max Description
limit 20 100 Results per page
page 1 100 Page number
shape compact — compact, standard, full

Example Response

{
  "facets": {
    "manufacturer": {
      "Johnson & Johnson Consumer Inc.": 12,
      "Novartis Consumer Health, Inc.": 8
    },
    "pharm_class_epc": {
      "Nonsteroidal Anti-inflammatory Drug [EPC]": 15,
      "Analgesic [EPC]": 10
    },
    "product_type": {
      "otc": 45,
      "rx": 12
    },
    "route": {
      "oral": 40,
      "topical": 10
    }
  },
  "has_more": true,
  "items": [
    {
      "id": "d1e5f6a7-8b9c-4d0e-a1b2-c3d4e5f6a7b8",
      "name": "TYLENOL Extra Strength",
      "brand_name": "TYLENOL",
      "generic_name": "ACETAMINOPHEN",
      "product_type": "otc",
      "route": ["oral"],
      "manufacturer": "Johnson & Johnson Consumer Inc."
    },
    {
      "id": "a2b3c4d5-e6f7-8a9b-0c1d-2e3f4a5b6c7d",
      "name": "Acetaminophen Tablets",
      "brand_name": null,
      "generic_name": "ACETAMINOPHEN",
      "product_type": "otc",
      "route": ["oral"],
      "manufacturer": "Major Pharmaceuticals"
    }
  ],
  "limit": 2,
  "meta": {
    "legal": {
      "attribution_required": false,
      "citation": "FDA Structured Product Labeling (SPL). Accessed 2026-01-28 via FHIRfly.",
      "license": "public_domain",
      "source_name": "FDA SPL"
    }
  },
  "page": 1,
  "total": 57,
  "total_capped": false
}

Use Cases

Find OTC Pain Relievers

Node.js
const results = await client.fdaLabel.search({
  q: "pain relief",
  product_type: "otc"
});

Find Prescription Drugs by Manufacturer

Node.js
const results = await client.fdaLabel.search({
  manufacturer: "pfizer",
  product_type: "rx"
});

Find Labels by NDC

Node.js
const results = await client.fdaLabel.search({
  ndc: "0363-0225"
});

Find Labels with RxNorm Linkage

Node.js
const results = await client.fdaLabel.search({
  q: "metformin",
  has_rxcui: true
});

Search by Pharmacologic Class

Node.js
const results = await client.fdaLabel.search({
  pharm_class: "Proton Pump Inhibitor"
});

Find Topical Medications

Node.js
const results = await client.fdaLabel.search({
  route: "topical",
  product_type: "otc"
});

Facets

FDA Label search returns these facets:

Facet Description
product_type Distribution by OTC/Rx/cellular
route Distribution by administration route
pharm_class_epc Distribution by established pharmacologic class
manufacturer Top manufacturers in results

Valid Values

Product Type Values

  • otc — Over-the-counter drugs
  • rx — Prescription drugs
  • cellular — Cellular/gene therapy products

Common Route Values

  • oral — Oral administration
  • topical — Applied to skin
  • intravenous — IV injection
  • intramuscular — IM injection
  • subcutaneous — Subcutaneous injection
  • inhalation — Inhaled
  • ophthalmic — Eye drops
  • otic — Ear drops
  • nasal — Nasal spray
  • rectal — Rectal administration
  • transdermal — Skin patch

Required Scope

fda-label.search

See Also