Data source guide

DailyMed: search drug labels and package inserts

DailyMed is the National Library of Medicine's site for the drug labels companies submit to FDA. Here is how to search DailyMed for a label or package insert, how to trace a label's version history, what DailyMed does not guarantee, and how ClinicaLister puts the label next to the drug's approvals and trials.

What is DailyMed?

DailyMed publishes product labeling in Structured Product Labeling (SPL), the format companies use to submit labels to FDA. It covers prescription drug and biologic labels — prescribing information, patient labeling, carton and container labels — and over-the-counter Drug Facts, plus some medical devices, medical gases and animal drugs.

It also carries labels for products FDA regulates but has not approved, such as dietary supplements, medical foods, cosmetics and some unapproved drugs. Each label has a set ID that stays the same across revisions and a version number that increases with every update.

Pharmacists, medical information teams and MSLs use it daily because it shows the label currently in use, including indications, dosing, warnings, adverse reactions and how the product is supplied with its NDC codes.

Updated
Labels appear as companies submit them to FDA

How to search DailyMed

DailyMed has a quick search, an advanced search and free web services; every label also keeps its own history.

  1. 1

    Search by drug name

    Type a brand or generic name into the search box on dailymed.nlm.nih.gov, filter to human or animal drugs, then open the label that matches the manufacturer and strength you need.

  2. 2

    Use advanced search for codes and label sections

    Advanced Search takes an NDC code, application number, set ID, drug class, active moiety, ingredient or UNII code, and can search inside label sections such as the Boxed Warning or Adverse Reactions. Browse Drug Classes groups labels by pharmacologic class.

  3. 3

    Trace the label's history

    Every label keeps its set ID across revisions while its version number increases. Listing the versions — through the web service below — shows when the label changed, so you can compare what was added.

  4. 4

    Use the web services for automation

    The DailyMed web services return labels as JSON or XML. For example /dailymed/services/v2/spls.json?drug_name=tirzepatide lists matching labels, and /services/v2/spls/{setid}/history.json lists every version of one label.

  5. 5

    Download labels in bulk

    DailyMed offers full downloads of all drug labels, indexing and REMS files, and mapping files that connect labels to other identifiers.

Limits of the official search

  • Labels are published as the company submitted them, and NLM does not review SPL content before publication. For the current FDA-approved labeling, DailyMed itself points to Drugs@FDA.
  • Some products are not FDA-approved at all — supplements, cosmetics and certain unapproved drugs — so being on DailyMed says nothing about approval status.
  • Each labeler submits its own label, so a common generic can return dozens of near-identical results from different companies.
  • Labels are not linked to the drug's clinical trials, its adverse-event reports or its patents.

What ClinicaLister adds to DailyMed

The label inside the drug view

ClinicaLister loads DailyMed labels daily and shows them in the same view as the drug's approvals, NDC listings, patents and safety summary, so medical information questions start from one place.

Next to the clinical evidence

The molecule view shows the label beside the drug's clinical trials and the publications linked to them, which is how an MSL prepares to discuss an indication or an emerging study.

Every label searchable, linked where it can be

All labels are searchable, including supplements and over-the-counter products. Where a label maps to a Drugs@FDA application — by application number first, then by name — it also joins the drug's approval record.

Ask your AI assistant

Through the ClinicaLister MCP server an assistant can look up a drug's labels and read them alongside its trials and approvals.

DailyMed in ClinicaLister

159,000+

DailyMed labels

Daily

sync from DailyMed

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labels linked to a Drugs@FDA record

ClinicaLister holds essentially all DailyMed labels (measured September 2026). About a third are linked to a Drugs@FDA record; the rest — supplements, devices, OTC monograph products and others — are searchable but not linked. Revisions to an existing label are not yet shown as changes.

DailyMed: frequently asked questions

What is DailyMed?

DailyMed is the National Library of Medicine's public website for drug labeling submitted to FDA — package inserts, patient information, Drug Facts and carton labels — in Structured Product Labeling format.

Is DailyMed labeling FDA-approved?

Not necessarily. DailyMed shows the labeling companies submitted, and NLM does not review it before publication. It also includes products FDA has not approved, such as dietary supplements. For the current FDA-approved label, check Drugs@FDA.

How do I see older versions of a drug label?

Each label keeps one set ID across all its versions. The DailyMed web service /services/v2/spls/{setid}/history.json returns the list of versions with their publication dates.

What is the difference between DailyMed and Drugs@FDA?

DailyMed shows the label each company has submitted and currently uses, for approved and unapproved products alike. Drugs@FDA is FDA's record of approved applications and, for many brand-name drugs, the FDA-approved label and review documents.

Is DailyMed free to use?

Yes. The website, web services and bulk downloads are free from the National Library of Medicine.