XtraCare Instant Hand Sanitizer

NDC product · U.S. Food and Drug Administration (openFDA) · United States

  • Product NDC 57337-059
  • Package NDC 57337-059-02
  • Application number M003
  • SPL ID 126e086f-ebda-cffb-e063-6294a90afdc5
  • SPL set ID a339dfd9-7cb8-4198-bc2a-9759648cf34e
  • UNII 3K9958V90M
  • RxCUI 247835

What the source publishes

Labeler
Rejoice International
Active ingredients
Ethyl Alcohol
Form
LIQUID
Routes
TOPICAL
Administrative status
present-in-source-snapshot
Marketing status
OTC MONOGRAPH DRUG
Product type
HUMAN OTC DRUG
Prescription
Non-prescription

Names this record is found by

Complete source data
us:fda:ndc:57337-059_126e086f-ebda-cffb-e063-6294a90afdc5
{
  "name": "XtraCare Instant Hand Sanitizer",
  "splId": "126e086f-ebda-cffb-e063-6294a90afdc5",
  "labels": [
    {
      "setId": "a339dfd9-7cb8-4198-bc2a-9759648cf34e",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a339dfd9-7cb8-4198-bc2a-9759648cf34e",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=a339dfd9-7cb8-4198-bc2a-9759648cf34e"
    }
  ],
  "routes": [
    "TOPICAL"
  ],
  "labeler": "Rejoice International",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "2 PACKAGE in 1 PACKAGE (57337-059-02)  / 60 g in 1 PACKAGE (57337-059-01)",
      "package_ndc": "57337-059-02",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20140218"
    }
  ],
  "productId": "57337-059_126e086f-ebda-cffb-e063-6294a90afdc5",
  "useDomain": "unknown",
  "dosageForm": "LIQUID",
  "productNdc": "57337-059",
  "deaSchedule": null,
  "genericName": "Ethyl Alcohol",
  "productType": "HUMAN OTC DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "ALCOHOL",
      "strength": "37 g/60g"
    }
  ],
  "applicationNumber": "M003",
  "marketingCategory": "OTC MONOGRAPH DRUG",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20140218",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "non-prescription",
  "harmonizedIdentifiers": {
    "upc": [
      "0849607054005"
    ],
    "unii": [
      "3K9958V90M"
    ],
    "rxcui": [
      "247835"
    ],
    "spl_set_id": [
      "a339dfd9-7cb8-4198-bc2a-9759648cf34e"
    ],
    "manufacturer_name": [
      "Rejoice International"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20271231"
}

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