Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA’s Labeling Resources for Human Prescription Drugs

FDA’s Labeling Resources for Human Prescription Drugs

                        Prescribing Information Resources
          Patient Labeling Resources
          Carton and Container Labeling Resources
          Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
          Generic Drugs - Specific Labeling Resources
          Biological Products - Specific Labeling Resources
          Frequently Asked Questions about Labeling for Prescription Medicines
          Prescription Drug Labeling Contact Information Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Laws, Acts, and Rules
          FDA’s Labeling Resources for Human Prescription Drugs
          Selection of Appropriate SPL Codes for Human Prescription Drug LabelingFDA’s Labeling Resources for Human Prescription Drugs Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
  
  					For SPL Drug Developers
	
    Share
    Post
    Linkedin

    Email
    PrintThis supplementary webpage is primarily directed to Structured Product Labeling (SPL) developers to assist in selection of appropriate SPL codes for human prescription drug* labeling.  See the main SPL resources webpage for additional SPL resources (e.g., guidances implementation guides and validation procedures, style sheets) and the Electronic Drug Registration and Listing Instructions webpage for instructions on how to register an establishment and list a drug with the FDA. For more information about:

Other prescription drug labeling resources for industry such as those for the Prescribing Information, FDA-approved patient labeling, carton and container labeling, generic drug labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs.
	Drug labeling resources for healthcare professionals, patients, and caregivers, visit Frequently Asked Questions about Labeling for Prescription Medicines.SPL is standard format for the electronic submission of the content of labeling:

Prescribing Information (PI) and
	FDA-approved patient labeling [e.g., Medication Guides (MG), Patient Package Inserts (PPI), and Instructions for Use (IFU)].When creating SPL, FDA encourages application holders to select the most specific, appropriate Logical Observation Identifiers Names and Codes (LOINC) to allow SPL users to identify content within each section and subsection of the PI and to identify content in different types of prescription drug labeling (e.g., PI, MG, PPI, IFU, or carton/container labeling).  For additional information on the rationale for appropriate selection of LOINC names and codes for human prescription drug labeling see *Improving the Accuracy of SPL Submissions – The Missing LOINC* (2019 presentation and video).

SPL Prescription Drug Labeling Guidances

Indexing Structured Product Labeling (final guidance)
	Providing Regulatory Submissions in Electronic Format - Content of Labeling (final guidance)
	Public Availability of Labeling Changes in “Changes Being Effected” Supplements (draft guidance)
	SPL Standard for Content of Labeling Technical Questions and Answers (draft guidance)Contact Information

For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.

                                                                                  Content current as of:
      05/22/2023
              
              
Regulated Product(s)
		 DrugsFDA’s Labeling Resources for Human Prescription Drugs

          
                        Prescribing Information Resources
          Patient Labeling Resources
          Carton and Container Labeling Resources
          Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
          Generic Drugs - Specific Labeling Resources
          Biological Products - Specific Labeling Resources
          Frequently Asked Questions about Labeling for Prescription Medicines
          Prescription Drug Labeling Contact Information
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop