Link Search Menu Expand Document

DailyMed Guide

Table of contents

  1. Getting started
  2. Basic structure
    1. Main SPL sections
    2. Important features
  3. Available data
    1. REST API
    2. Drug label downloads
    3. Mapping files
    4. Indexing and REMS files

Getting started

DailyMed is the official provider of FDA structured product label (SPL) information (package inserts).

Check out the DailyMed website.

Basic structure

Each SPL has a unique set ID that does not change over time. However, with every update to an SPL, the SPL ID and SPL version can change.

Example label (note the set ID in the URL): LISINOPRIL tablet

There are links from this page to download the label info in PDF or XML format, as well as in the official label format.

Main SPL sections

  • NDC code(s)
  • Packager
  • Category
  • DEA schedule
  • Marketing status
  • Date last updated
  • Drug label information
    • Highlights of prescribing information
    • Table of contents
    • Boxed warning
    • Indications and usage
    • Dosage and administration
    • Dosage forms and strengths
    • Contraindications
    • Warnings and precautions
    • Adverse reactions
    • Drug interactions
    • Use in specific populations
    • Overdosage
    • Description
    • Clinical pharmacology
    • Nonclinical toxicology
    • Clinical studies
    • How supplied/storage and handling
    • Patient counseling information
    • Principal display panel
    • Ingredients and appearance

Important features

Feature name Description
Package photos Images of the drug packages, but not NDC-specific.
Drug photos Images of the actual drug, associated with NDC.
Labeling archives Download previous versions of SPLs.
RxNorm Maps RXCUIs of different term types (TTY) to set IDs.

NOTE: this mapping is specific to a set, not to a product or package.
Label RSS feed Subscribe to updates to DailyMed labels via RSS.
Biochemical data summary Links to DrugBank which is a pharmaceutical knowledge base.
NDC codes All NDC codes associated with the SPL.

Available data


DailyMed provides a REST API with the following endpoints.

The base URL is to which you can append the below endpoints. Some endpoints return either XML or JSON, while others only return XML.

REST web service resources Description
/applicationnumbers Returns a list of all NDA numbers.
/drugclasses Returns a list of all drug classes associated with at least one SPL in the Pharmacologic Class Indexing Files.
/drugnames Returns a list of all drug names.
/NDCs Returns a list of all NDC codes.
/rxcuis Returns a list of all product-level RxCUIs.
/spls Returns a list of all SPLs.
/spls/{SETID} Returns an SPL document for specific set ID.
/spls/{SETID}/history Returns version history for specific set ID.
/spls/{SETID}/media Returns links to all media for specific set ID.
/spls/{SETID}/NDCs Returns all NDCs for specific set ID.
/spls/{SETID}/packaging Returns all product packaging descriptions for specific set ID.
/uniis Returns a list of all UNIIs.

Source: DailyMed web services

Drug label downloads

Drug label downloads are available in zip file format, which contain images from the SPL and the entire SPL in XML file format.

Two different formats are provided depending on whether you want to stay on top of every incremental update, or just download the full release.

  1. Periodic updates (monthly, weekly, or daily) of all drug labels.
  2. Full releases of different types of drug labels. Human labels are split across multiple zip files due to file size.
    • Human prescription labels
    • Human OTC labels
    • Homeopathic labels
    • Animal labels
    • Remainder labels

Mapping files

Mapping file downloads are available in zip file format.

  • SPL-RxNorm
  • SPL-pharmacologic class
  • Zip file metadata

Indexing and REMS files

Indexing and REMS file downloads are available in zip file format.

  • Billing unit
  • Biologic or drug substance
  • FDA-initiated compliance action - drug listing
  • Pharmacologic class
  • Product concept
  • REMS and REMS indexing
  • Substance
  • Warning letter alert