FDALabel Disclaimer:

Data Source
The source of FDALabel’s data is DailyMed’s Structured Product Labeling (SPL) archive which contains the most recent labeling documents submitted by companies ("in use" labeling). The SPL documents found on FDALabel are also found on DailyMed and FDA Online Label Repository. FDALabel is implemented as a secure three-tier application with an Oracle database.

Differences Between SPL and FDA-Approved Labeling
The labeling in the SPL documents may not be identical to the most recent FDA-approved labeling available at Drugs@FDA, and the contents of the SPL documents (including data element entries in the SPL files) have not been verified by the FDA. For example:

  • The dosage form(s) and the route(s) of administration (ROA) listed in the output page, along with the ROA listed in the ROA search box, are derived from the Data Standards Manual (DSM) terminology. These terms may not be consistent with United States Pharmacopeia (USP) terminology or terminology used in FDA-approved labeling.
  • The marketing date(s) listed may not always accurately represent the date that the product was first marketed.
  • Compared with the most recent FDA-approved labeling, the SPL document may contain minor changes (e.g., editorial changes such as adding a distributor’s name) or moderate changes that are undergoing FDA review (e.g., adding or strengthening a warning or adverse reaction).

For information regarding types of changes to labeling that may result in differences between the SPL labeling from the most recent FDA-approved labeling, see 21 CFR 314.70, 21 CFR 601.12, and the Guidance for Industry: Changes to an Approved NDA or ANDA.

Because the SPL documents on FDALabel may not be identical to the most recent FDA-approved labeling, visit the following sites for the most current FDA-approved labeling:

  • Drugs@FDA for human prescription drug and biological products and for OTC drugs approved under an NDA or ANDA;
  • Biologics Products & Establishments for human blood and blood products; plasma derivatives; vaccines, allergenic products, and cellular and gene therapy products; and products regulated by CBER under an NDA or ANDA (e.g., Plasma Volume Expanders).

Limitations of Product Title Search of PLR Format Labeling
Because of how SPL documents are structured, an FDALabel product title search of PLR format labeling [performed via the "Product Title" option in the Labeling Section(s) search box] may include some labeling for which the queried text is not in the product title. For example, the product title search may result in some labeling that have the queried text appearing in the Highlights Limitation Statement, the Initial U.S. Approval, or the biosimilarity statement for biosimilar products.

Limitations of Product Title Search
Because of how SPL documents are structured, an FDALabel product title search [performed via the "Product Title" option in the Labeling Section(s) search box] may include some labeling for which the queried text is not in the product title. For example, the product title search may result in some labeling that have the queried text appearing in the Highlights Limitation Statement, the Initial U.S. Approval, or the biosimilarity statement for biosimilar products.

Nonprescription Drugs
Many nonprescription drugs (e.g., OTC drugs) are not reviewed and approved by the FDA (e.g., drugs marketed under a final monograph or a tentative final monograph); however, these OTC drugs may be marketed if they comply with applicable OTC monographs. The labeling for drugs marked "OTC monograph final" or "OTC monograph not final" in FDALabel are not checked for conformance to the OTC monograph. A search for the "Human OTC Drugs" labeling type in FDALabel retrieves nonprescription drugs that are OTC as well as nonprescription products available behind the pharmacy counter (e.g., nonprescription insulin products).

Query/Result Links in Spreadsheet
Clicking "CSV" or "Excel" next to Download Full Results near the upper-right corner of the search results page will export the entire search output to a CSV file or an Excel file, respectively (both exported file formats can be opened as spreadsheets in Microsoft Excel). The exported file also includes the following three items: (1) the link to the search query for the entire search output, (2) the link to the search results for the entire search output, and (3) the export date and time for the entire search output. When locating these three items in the exported file in Microsoft Excel, note the following:

  • In the CSV file (file ends in ".csv"), there will be a single spreadsheet that contains the entire search output followed by items (1), (2), and (3) above as the last three columns of the spreadsheet. Although the information in these three columns appears in the first row of data (i.e., after the title row), these three items are associated with the entire search output, not just the first row of data.
  • In the Excel file (file ends in ".xlsx"), there will be two spreadsheets. The first spreadsheet contains the entire search output, and the second spreadsheet (named "Query Links") contains items (1), (2), and (3) above.

MedDRA Terms Search and Report
The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized medical terminology developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MedDRA features developed in FDALabel are intended to facilitate the study of adverse event (AE) occurrences in product labeling. It should be noted that MedDRA version updates, which occur on a biannual basis, may affect search results due to changes in mapping or promotion/demotion of MedDRA terms. FDALabel updates MedDRA terminology at least once a year during a new version release. The FDA does not require AEs to be described with MedDRA terminology in labeling. Thus, a MedDRA term search or report in FDALabel may not represent all AE concepts represented in labeling. Furthermore, the presence of a MedDRA term in labeling may not necessarily refer to an AE (e.g., MedDRA terms may correspond to indications or patient comorbidities). During the application of the MedDRA features in FDALabel, specific rules (see PDF) were defined for applying Natural Language Processing (NLP) using MedDRA. Labeling documents (SPL: Structured Product Labeling) are indexed by MedDRA Lowest Level Terms (LLTs) following the predefined MedDRA rules. MedDRA LLTs, extracted from a SPL, are mapped to Preferred Terms (PTs) for the MedDRA report. If a non-standard section heading in the SPL mentioned clinical trial, postmarketing experience, or related terms, a rule-based algorithm was utilized to map the MedDRA terms to either section 6.1 Clinical Trials Experience or 6.2 Postmarketing Experience, respectively. Users should manually confirm the occurrence of MedDRA terms in the labeling sections of the MedDRA report.