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"
});

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

FDA Labels Search API

Endpoint

Quick Start

Parameters

Text Search

Filters

Example Response

Use Cases

Find OTC Pain Relievers

Find Prescription Drugs by Manufacturer

Find Labels by NDC

Find Labels with RxNorm Linkage

Search by Pharmacologic Class

Find Topical Medications

Facets

Valid Values

Product Type Values

Common Route Values

Required Scope

See Also

FDA Labels Search API

Endpoint

Quick Start

Parameters

Text Search

Filters

Pagination & Response

Example Response

Use Cases

Find OTC Pain Relievers

Find Prescription Drugs by Manufacturer

Find Labels by NDC

Find Labels with RxNorm Linkage

Search by Pharmacologic Class

Find Topical Medications

Facets

Valid Values

Product Type Values

Common Route Values

Required Scope

See Also

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