SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI United States of America flag

SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

: SPL Document Codes - JSON Representation

Page standards status: Trial-use Maturity Level: 1

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{
  "resourceType" : "ValueSet",
  "id" : "splDocumentCodes",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Include these codes as defined in <a href=\"http://loinc.org\"><code>http://loinc.org</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"https://loinc.org/101437-2/\">101437-2</a></td><td>Intentional animal genomic alteration label</td></tr><tr><td><a href=\"https://loinc.org/104085-6/\">104085-6</a></td><td>Cosmetic facility registration</td></tr><tr><td><a href=\"https://loinc.org/104086-4/\">104086-4</a></td><td>Cosmetic facility registration-amendment</td></tr><tr><td><a href=\"https://loinc.org/104087-2/\">104087-2</a></td><td>Cosmetic facility registration-abbreviated renewal</td></tr><tr><td><a href=\"https://loinc.org/104088-0/\">104088-0</a></td><td>Cosmetic facility registration-cancellation</td></tr><tr><td><a href=\"https://loinc.org/104089-8/\">104089-8</a></td><td>Cosmetic facility registration-biennial renewal</td></tr><tr><td><a href=\"https://loinc.org/104090-6/\">104090-6</a></td><td>Cosmetic-abbreviated renewal</td></tr><tr><td><a href=\"https://loinc.org/104091-4/\">104091-4</a></td><td>Animal drug for further processing</td></tr><tr><td><a href=\"https://loinc.org/34390-5/\">34390-5</a></td><td>Human OTC drug label</td></tr><tr><td><a href=\"https://loinc.org/34391-3/\">34391-3</a></td><td>Human prescription drug label</td></tr><tr><td><a href=\"https://loinc.org/45129-4/\">45129-4</a></td><td>Human prescription drug label with highlights</td></tr><tr><td><a href=\"https://loinc.org/50565-1/\">50565-1</a></td><td>OTC - Keep out of reach of children section</td></tr><tr><td><a href=\"https://loinc.org/50566-9/\">50566-9</a></td><td>OTC - Stop use section</td></tr><tr><td><a href=\"https://loinc.org/50567-7/\">50567-7</a></td><td>OTC - When using section</td></tr><tr><td><a href=\"https://loinc.org/50568-5/\">50568-5</a></td><td>OTC - Ask doctor or pharmacist section</td></tr><tr><td><a href=\"https://loinc.org/50569-3/\">50569-3</a></td><td>OTC - Ask doctor section</td></tr><tr><td><a href=\"https://loinc.org/50570-1/\">50570-1</a></td><td>OTC - Do not use section</td></tr><tr><td><a href=\"https://loinc.org/50571-9/\">50571-9</a></td><td>VFD Type C medicated feed animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50572-7/\">50572-7</a></td><td>VFD Type B medicated feed animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50573-5/\">50573-5</a></td><td>OTC Type C medicated feed animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50574-3/\">50574-3</a></td><td>OTC Type B medicated feed animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50575-0/\">50575-0</a></td><td>VFD Type A medicated article animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50576-8/\">50576-8</a></td><td>OTC Type A medicated article animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50577-6/\">50577-6</a></td><td>OTC animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50578-4/\">50578-4</a></td><td>Prescription animal drug label</td></tr><tr><td><a href=\"https://loinc.org/50740-0/\">50740-0</a></td><td>Guaranteed analysis of feed section</td></tr><tr><td><a href=\"https://loinc.org/50741-8/\">50741-8</a></td><td>Safe handling warning section</td></tr><tr><td><a href=\"https://loinc.org/50742-6/\">50742-6</a></td><td>Environmental warning section</td></tr><tr><td><a href=\"https://loinc.org/50743-4/\">50743-4</a></td><td>Food safety warning section</td></tr><tr><td><a href=\"https://loinc.org/50744-2/\">50744-2</a></td><td>Information for owners or caregivers section</td></tr><tr><td><a href=\"https://loinc.org/50745-9/\">50745-9</a></td><td>Veterinary indications section</td></tr><tr><td><a href=\"https://loinc.org/51725-0/\">51725-0</a></td><td>Establishment registration</td></tr><tr><td><a href=\"https://loinc.org/51726-8/\">51726-8</a></td><td>NDC labeler code request</td></tr><tr><td><a href=\"https://loinc.org/51727-6/\">51727-6</a></td><td>Inactive ingredient section</td></tr><tr><td><a href=\"https://loinc.org/51941-3/\">51941-3</a></td><td>Back panel of package</td></tr><tr><td><a href=\"https://loinc.org/51942-1/\">51942-1</a></td><td>Side panel of package Right</td></tr><tr><td><a href=\"https://loinc.org/51943-9/\">51943-9</a></td><td>Side panel of package Left</td></tr><tr><td><a href=\"https://loinc.org/51944-7/\">51944-7</a></td><td>Side panel of package</td></tr><tr><td><a href=\"https://loinc.org/51945-4/\">51945-4</a></td><td>Principal display panel of package</td></tr><tr><td><a href=\"https://loinc.org/51946-2/\">51946-2</a></td><td>Top panel of package</td></tr><tr><td><a href=\"https://loinc.org/51947-0/\">51947-0</a></td><td>Bottom panel of package</td></tr><tr><td><a href=\"https://loinc.org/51948-8/\">51948-8</a></td><td>Flap panel of package</td></tr><tr><td><a href=\"https://loinc.org/53404-0/\">53404-0</a></td><td>Vaccine label</td></tr><tr><td><a href=\"https://loinc.org/53405-7/\">53405-7</a></td><td>Non-standardized allergenic label</td></tr><tr><td><a href=\"https://loinc.org/53406-5/\">53406-5</a></td><td>Licensed vaccine bulk intermediate label</td></tr><tr><td><a href=\"https://loinc.org/53407-3/\">53407-3</a></td><td>Licensed blood intermediate/paste label</td></tr><tr><td><a href=\"https://loinc.org/53408-1/\">53408-1</a></td><td>Licensed minimally manipulated cells label</td></tr><tr><td><a href=\"https://loinc.org/53409-9/\">53409-9</a></td><td>Bulk ingredient</td></tr><tr><td><a href=\"https://loinc.org/53410-7/\">53410-7</a></td><td>No change notification</td></tr><tr><td><a href=\"https://loinc.org/53411-5/\">53411-5</a></td><td>Out of business notification</td></tr><tr><td><a href=\"https://loinc.org/53412-3/\">53412-3</a></td><td>Residue warning section</td></tr><tr><td><a href=\"https://loinc.org/53413-1/\">53413-1</a></td><td>OTC - Questions section</td></tr><tr><td><a href=\"https://loinc.org/53414-9/\">53414-9</a></td><td>OTC - Pregnancy or breast feeding section</td></tr><tr><td><a href=\"https://loinc.org/55105-1/\">55105-1</a></td><td>OTC - Purpose section</td></tr><tr><td><a href=\"https://loinc.org/55106-9/\">55106-9</a></td><td>OTC - Active ingredient section</td></tr><tr><td><a href=\"https://loinc.org/55439-4/\">55439-4</a></td><td>Medical device</td></tr><tr><td><a href=\"https://loinc.org/58474-8/\">58474-8</a></td><td>Cosmetic</td></tr><tr><td><a href=\"https://loinc.org/58475-5/\">58475-5</a></td><td>Medical food</td></tr><tr><td><a href=\"https://loinc.org/58476-3/\">58476-3</a></td><td>Dietary supplement</td></tr><tr><td><a href=\"https://loinc.org/60682-2/\">60682-2</a></td><td>Standardized allergenic</td></tr><tr><td><a href=\"https://loinc.org/60683-0/\">60683-0</a></td><td>Plasma derivative</td></tr><tr><td><a href=\"https://loinc.org/60684-8/\">60684-8</a></td><td>Cellular therapy</td></tr><tr><td><a href=\"https://loinc.org/63417-0/\">63417-0</a></td><td>Indexing - Indication</td></tr><tr><td><a href=\"https://loinc.org/68498-5/\">68498-5</a></td><td>Patient medication information section</td></tr><tr><td><a href=\"https://loinc.org/69403-4/\">69403-4</a></td><td>OTC medical device label</td></tr><tr><td><a href=\"https://loinc.org/69404-2/\">69404-2</a></td><td>Prescription medical device label</td></tr><tr><td><a href=\"https://loinc.org/69718-5/\">69718-5</a></td><td>Statement of identity section</td></tr><tr><td><a href=\"https://loinc.org/69719-3/\">69719-3</a></td><td>Health claim section</td></tr><tr><td><a href=\"https://loinc.org/69968-6/\">69968-6</a></td><td>NDC labeler code inactivation</td></tr><tr><td><a href=\"https://loinc.org/70097-1/\">70097-1</a></td><td>Establishment de-registration</td></tr><tr><td><a href=\"https://loinc.org/71743-9/\">71743-9</a></td><td>Generic drug facility identification submission</td></tr><tr><td><a href=\"https://loinc.org/72090-4/\">72090-4</a></td><td>Identification of CBER-regulated generic drug facility</td></tr><tr><td><a href=\"https://loinc.org/72871-7/\">72871-7</a></td><td>NDC labeler code request - animal drug</td></tr><tr><td><a href=\"https://loinc.org/75030-7/\">75030-7</a></td><td>Wholesale drug distributors and third-party logistics facility registration</td></tr><tr><td><a href=\"https://loinc.org/75031-5/\">75031-5</a></td><td>Human compounded drug label</td></tr><tr><td><a href=\"https://loinc.org/77573-4/\">77573-4</a></td><td>Withdrawal of wholesale drug distributors and third-party logistics facility report</td></tr><tr><td><a href=\"https://loinc.org/77647-6/\">77647-6</a></td><td>Animal compounded drug label</td></tr><tr><td><a href=\"https://loinc.org/77648-4/\">77648-4</a></td><td>Indexing - biologic or drug substance</td></tr><tr><td><a href=\"https://loinc.org/78744-0/\">78744-0</a></td><td>Drug for further processing label</td></tr><tr><td><a href=\"https://loinc.org/78745-7/\">78745-7</a></td><td>Recombinant deoxyribonucleic acid construct label</td></tr><tr><td><a href=\"https://loinc.org/81203-2/\">81203-2</a></td><td>Bulk ingredient - animal drug</td></tr><tr><td><a href=\"https://loinc.org/81204-0/\">81204-0</a></td><td>NDC labeler code inactivation - animal drug</td></tr><tr><td><a href=\"https://loinc.org/85480-2/\">85480-2</a></td><td>Establishment registration exempt notification</td></tr><tr><td><a href=\"https://loinc.org/85481-0/\">85481-0</a></td><td>Blood establishment registration and product listing</td></tr><tr><td><a href=\"https://loinc.org/85482-8/\">85482-8</a></td><td>Human cell and tissue establishment registration and product listing</td></tr><tr><td><a href=\"https://loinc.org/85484-4/\">85484-4</a></td><td>Establishment temporary inactivation notification</td></tr><tr><td><a href=\"https://loinc.org/86444-7/\">86444-7</a></td><td>Manufacturing establishment information</td></tr><tr><td><a href=\"https://loinc.org/86446-2/\">86446-2</a></td><td>Blood establishment registration and product listing change in information</td></tr><tr><td><a href=\"https://loinc.org/86447-0/\">86447-0</a></td><td>Human cell and tissue establishment registration and product listing change in information</td></tr><tr><td><a href=\"https://loinc.org/86448-8/\">86448-8</a></td><td>Human salvaged drug</td></tr><tr><td><a href=\"https://loinc.org/89600-1/\">89600-1</a></td><td>FDA-initiated compliance action drug registration and listing inactivation</td></tr><tr><td><a href=\"https://loinc.org/93372-1/\">93372-1</a></td><td>Indexing - national clinical trial number</td></tr><tr><td><a href=\"https://loinc.org/93723-5/\">93723-5</a></td><td>Indexing - drug interactions</td></tr><tr><td><a href=\"https://loinc.org/98075-5/\">98075-5</a></td><td>Animal cells, tissues, and cell and tissue based product label</td></tr><tr><td><a href=\"https://loinc.org/99282-6/\">99282-6</a></td><td>FDA-initiated compliance action drug registration and listing inactivation - animal drug</td></tr></table></li></ul></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 1,
      "_valueInteger" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use",
      "_valueCode" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/us/spl/ValueSet/splDocumentCodes",
  "version" : "0.1.0",
  "name" : "SPLDocumentCodes",
  "title" : "SPL Document Codes",
  "status" : "active",
  "experimental" : false,
  "date" : "2024-06-04T14:24:17+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description" : "Document Codes for SPL Product Submission documents",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "copyright" : "This material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.",
  "compose" : {
    "include" : [
      {
        "system" : "http://loinc.org",
        "concept" : [
          {
            "code" : "101437-2",
            "display" : "Intentional animal genomic alteration label"
          },
          {
            "code" : "104085-6",
            "display" : "Cosmetic facility registration"
          },
          {
            "code" : "104086-4",
            "display" : "Cosmetic facility registration-amendment"
          },
          {
            "code" : "104087-2",
            "display" : "Cosmetic facility registration-abbreviated renewal"
          },
          {
            "code" : "104088-0",
            "display" : "Cosmetic facility registration-cancellation"
          },
          {
            "code" : "104089-8",
            "display" : "Cosmetic facility registration-biennial renewal"
          },
          {
            "code" : "104090-6",
            "display" : "Cosmetic-abbreviated renewal"
          },
          {
            "code" : "104091-4",
            "display" : "Animal drug for further processing"
          },
          {
            "code" : "34390-5",
            "display" : "Human OTC drug label"
          },
          {
            "code" : "34391-3",
            "display" : "Human prescription drug label"
          },
          {
            "code" : "45129-4",
            "display" : "Human prescription drug label with highlights"
          },
          {
            "code" : "50565-1",
            "display" : "OTC - Keep out of reach of children section"
          },
          {
            "code" : "50566-9",
            "display" : "OTC - Stop use section"
          },
          {
            "code" : "50567-7",
            "display" : "OTC - When using section"
          },
          {
            "code" : "50568-5",
            "display" : "OTC - Ask doctor or pharmacist section"
          },
          {
            "code" : "50569-3",
            "display" : "OTC - Ask doctor section"
          },
          {
            "code" : "50570-1",
            "display" : "OTC - Do not use section"
          },
          {
            "code" : "50571-9",
            "display" : "VFD Type C medicated feed animal drug label"
          },
          {
            "code" : "50572-7",
            "display" : "VFD Type B medicated feed animal drug label"
          },
          {
            "code" : "50573-5",
            "display" : "OTC Type C medicated feed animal drug label"
          },
          {
            "code" : "50574-3",
            "display" : "OTC Type B medicated feed animal drug label"
          },
          {
            "code" : "50575-0",
            "display" : "VFD Type A medicated article animal drug label"
          },
          {
            "code" : "50576-8",
            "display" : "OTC Type A medicated article animal drug label"
          },
          {
            "code" : "50577-6",
            "display" : "OTC animal drug label"
          },
          {
            "code" : "50578-4",
            "display" : "Prescription animal drug label"
          },
          {
            "code" : "50740-0",
            "display" : "Guaranteed analysis of feed section"
          },
          {
            "code" : "50741-8",
            "display" : "Safe handling warning section"
          },
          {
            "code" : "50742-6",
            "display" : "Environmental warning section"
          },
          {
            "code" : "50743-4",
            "display" : "Food safety warning section"
          },
          {
            "code" : "50744-2",
            "display" : "Information for owners or caregivers section"
          },
          {
            "code" : "50745-9",
            "display" : "Veterinary indications section"
          },
          {
            "code" : "51725-0",
            "display" : "Establishment registration"
          },
          {
            "code" : "51726-8",
            "display" : "NDC labeler code request"
          },
          {
            "code" : "51727-6",
            "display" : "Inactive ingredient section"
          },
          {
            "code" : "51941-3",
            "display" : "Back panel of package"
          },
          {
            "code" : "51942-1",
            "display" : "Side panel of package Right"
          },
          {
            "code" : "51943-9",
            "display" : "Side panel of package Left"
          },
          {
            "code" : "51944-7",
            "display" : "Side panel of package"
          },
          {
            "code" : "51945-4",
            "display" : "Principal display panel of package"
          },
          {
            "code" : "51946-2",
            "display" : "Top panel of package"
          },
          {
            "code" : "51947-0",
            "display" : "Bottom panel of package"
          },
          {
            "code" : "51948-8",
            "display" : "Flap panel of package"
          },
          {
            "code" : "53404-0",
            "display" : "Vaccine label"
          },
          {
            "code" : "53405-7",
            "display" : "Non-standardized allergenic label"
          },
          {
            "code" : "53406-5",
            "display" : "Licensed vaccine bulk intermediate label"
          },
          {
            "code" : "53407-3",
            "display" : "Licensed blood intermediate/paste label"
          },
          {
            "code" : "53408-1",
            "display" : "Licensed minimally manipulated cells label"
          },
          {
            "code" : "53409-9",
            "display" : "Bulk ingredient"
          },
          {
            "code" : "53410-7",
            "display" : "No change notification"
          },
          {
            "code" : "53411-5",
            "display" : "Out of business notification"
          },
          {
            "code" : "53412-3",
            "display" : "Residue warning section"
          },
          {
            "code" : "53413-1",
            "display" : "OTC - Questions section"
          },
          {
            "code" : "53414-9",
            "display" : "OTC - Pregnancy or breast feeding section"
          },
          {
            "code" : "55105-1",
            "display" : "OTC - Purpose section"
          },
          {
            "code" : "55106-9",
            "display" : "OTC - Active ingredient section"
          },
          {
            "code" : "55439-4",
            "display" : "Medical device"
          },
          {
            "code" : "58474-8",
            "display" : "Cosmetic"
          },
          {
            "code" : "58475-5",
            "display" : "Medical food"
          },
          {
            "code" : "58476-3",
            "display" : "Dietary supplement"
          },
          {
            "code" : "60682-2",
            "display" : "Standardized allergenic"
          },
          {
            "code" : "60683-0",
            "display" : "Plasma derivative"
          },
          {
            "code" : "60684-8",
            "display" : "Cellular therapy"
          },
          {
            "code" : "63417-0",
            "display" : "Indexing - Indication"
          },
          {
            "code" : "68498-5",
            "display" : "Patient medication information section"
          },
          {
            "code" : "69403-4",
            "display" : "OTC medical device label"
          },
          {
            "code" : "69404-2",
            "display" : "Prescription medical device label"
          },
          {
            "code" : "69718-5",
            "display" : "Statement of identity section"
          },
          {
            "code" : "69719-3",
            "display" : "Health claim section"
          },
          {
            "code" : "69968-6",
            "display" : "NDC labeler code inactivation"
          },
          {
            "code" : "70097-1",
            "display" : "Establishment de-registration"
          },
          {
            "code" : "71743-9",
            "display" : "Generic drug facility identification submission"
          },
          {
            "code" : "72090-4",
            "display" : "Identification of CBER-regulated generic drug facility"
          },
          {
            "code" : "72871-7",
            "display" : "NDC labeler code request - animal drug"
          },
          {
            "code" : "75030-7",
            "display" : "Wholesale drug distributors and third-party logistics facility registration"
          },
          {
            "code" : "75031-5",
            "display" : "Human compounded drug label"
          },
          {
            "code" : "77573-4",
            "display" : "Withdrawal of wholesale drug distributors and third-party logistics facility report"
          },
          {
            "code" : "77647-6",
            "display" : "Animal compounded drug label"
          },
          {
            "code" : "77648-4",
            "display" : "Indexing - biologic or drug substance"
          },
          {
            "code" : "78744-0",
            "display" : "Drug for further processing label"
          },
          {
            "code" : "78745-7",
            "display" : "Recombinant deoxyribonucleic acid construct label"
          },
          {
            "code" : "81203-2",
            "display" : "Bulk ingredient - animal drug"
          },
          {
            "code" : "81204-0",
            "display" : "NDC labeler code inactivation - animal drug"
          },
          {
            "code" : "85480-2",
            "display" : "Establishment registration exempt notification"
          },
          {
            "code" : "85481-0",
            "display" : "Blood establishment registration and product listing"
          },
          {
            "code" : "85482-8",
            "display" : "Human cell and tissue establishment registration and product listing"
          },
          {
            "code" : "85484-4",
            "display" : "Establishment temporary inactivation notification"
          },
          {
            "code" : "86444-7",
            "display" : "Manufacturing establishment information"
          },
          {
            "code" : "86446-2",
            "display" : "Blood establishment registration and product listing change in information"
          },
          {
            "code" : "86447-0",
            "display" : "Human cell and tissue establishment registration and product listing change in information"
          },
          {
            "code" : "86448-8",
            "display" : "Human salvaged drug"
          },
          {
            "code" : "89600-1",
            "display" : "FDA-initiated compliance action drug registration and listing inactivation"
          },
          {
            "code" : "93372-1",
            "display" : "Indexing - national clinical trial number"
          },
          {
            "code" : "93723-5",
            "display" : "Indexing - drug interactions"
          },
          {
            "code" : "98075-5",
            "display" : "Animal cells, tissues, and cell and tissue based product label"
          },
          {
            "code" : "99282-6",
            "display" : "FDA-initiated compliance action drug registration and listing inactivation - animal drug"
          }
        ]
      }
    ]
  }
}