What Is Structured Product Labeling?

Are you curious to know what is structured product labeling? You have come to the right place as I am going to tell you everything about structured product labeling in a very simple explanation. Without further discussion let’s begin to know what is structured product labeling?

In the world of pharmaceuticals and healthcare, effective communication of drug information is of paramount importance. To streamline the exchange of critical drug data between various stakeholders, the Food and Drug Administration (FDA) introduced Structured Product Labeling (SPL). This standardized format has revolutionized the way drug information is organized, presented, and shared. In this blog, we will delve into the concept of Structured Product Labeling, its purpose, benefits, and its impact on the healthcare industry.

What Is Structured Product Labeling?

Structured Product Labeling is an XML-based standard for presenting drug information in a structured and machine-readable format. It was developed by the FDA as part of the Electronic Regulatory Submissions and Review (ERSR) initiative. SPL ensures consistency and accuracy in the presentation of drug product information across various platforms, systems, and databases. The format allows for easier electronic exchange of data and facilitates seamless integration of drug information into healthcare systems.

The Purpose Of Structured Product Labeling

  1. Enhancing Drug Safety: SPL aims to improve patient safety by providing comprehensive and standardized drug information, including indications, dosage, contraindications, warnings, and adverse reactions.
  2. Facilitating Regulatory Submissions: Pharmaceutical companies can use SPL to submit drug labeling information to regulatory authorities, such as the FDA, in a standardized and electronic format, streamlining the review process.
  3. Supporting Healthcare Information Systems: SPL facilitates the integration of drug information into electronic health records (EHRs), clinical decision support systems, and drug information databases, enabling healthcare providers to access accurate and up-to-date information.
  4. Improving Drug Knowledge Sharing: By adopting a common format, SPL enables seamless sharing of drug data between various stakeholders, including healthcare professionals, researchers, and regulatory agencies.

The Structure Of Structured Product Labeling

SPL is organized into several sections, each serving a specific purpose. The main sections of an SPL document include:

  1. SPL Header: Contains metadata about the label, such as the product’s NDC (National Drug Code) number, application type, and revision date.
  2. Drug Listing Information: Provides basic drug identification details, including the drug’s proprietary and generic names, strength, and route of administration.
  3. Indications and Usage: Describes the approved uses for the drug.
  4. Dosage and Administration: Outlines recommended dosing instructions for various patient populations.
  5. Contraindications: Lists conditions or patient groups for which the drug is not recommended.
  6. Warnings and Precautions: Highlights important safety information and potential adverse effects.
  7. Adverse Reactions: Enumerates known side effects of the drug.
  8. Drug Interactions: Identifies potential interactions with other medications or substances.

Benefits Of Structured Product Labeling

  1. Standardization: SPL ensures consistency in drug information presentation, reducing the risk of errors and confusion.
  2. Efficient Review Process: The electronic format streamlines the regulatory review process, making it faster and more efficient.
  3. Enhanced Patient Safety: Clear and standardized information on drug indications, dosages, and contraindications helps healthcare providers make informed decisions, leading to better patient outcomes.
  4. Interoperability: SPL facilitates interoperability between different healthcare systems, enabling seamless data exchange.


Structured Product Labeling has transformed the way drug information is organized, shared, and utilized in the healthcare industry. By adopting a standardized format, stakeholders can communicate critical drug data more efficiently, leading to improved patient safety and better healthcare decision-making. As technology continues to advance, SPL will play an increasingly vital role in supporting drug regulation, enhancing patient care, and promoting collaboration among healthcare professionals.

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What Is A Structured Product Labeling?

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

What Is The Spl Format?

Structured Product Labeling (SPL) is the FDA-required standard for formatting product and drug information, enabling data exchange in a consistent and machine-readable format. In addition, having a single format enables automated data processing and faster information retrieval.

How Do I Submit Spl To Fda?

Listing process

  1. Select the appropriate SPL document type for the product (human Rx drug, human OTC, bulk ingredient, etc.)
  2. Fill out all required listing data elements.
  3. Create a section within the SPL file for each section of content for labeling (e.g., highlights, warnings, how supplied) and enter the text for each.

What’s A Product Label?

What are product labels? Product labels are any piece of material attached to a product to identify it, or to a container to identify its contents. Information that is directly written on a product can also be considered a label.

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