Guaifenesin STRAWBERRY-BANANA FLAVOR

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

  • Product NDC 71800-059
  • Package NDC 71800-059-19
  • Application number M012
  • SPL ID 37de006a-e717-a4e5-e063-6394a90abd8b
  • SPL set ID 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16
  • UNII 495W7451VQ
  • RxCUI 310604

What the source publishes

Labeler
Innovida Pharmaeutique Corporation
Active ingredients
GUAIFENESIN
Form
LIQUID
Routes
ORAL
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:71800-059_37de006a-e717-a4e5-e063-6394a90abd8b
{
  "name": "Guaifenesin STRAWBERRY-BANANA FLAVOR",
  "splId": "37de006a-e717-a4e5-e063-6394a90abd8b",
  "labels": [
    {
      "setId": "1006906e-d6d7-4f49-92bf-3cb2d2cdbb16",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1006906e-d6d7-4f49-92bf-3cb2d2cdbb16",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=1006906e-d6d7-4f49-92bf-3cb2d2cdbb16"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "Innovida Pharmaeutique Corporation",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "119 mL in 1 TUBE (71800-059-19)",
      "package_ndc": "71800-059-19",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20250616"
    }
  ],
  "productId": "71800-059_37de006a-e717-a4e5-e063-6394a90abd8b",
  "useDomain": "unknown",
  "dosageForm": "LIQUID",
  "productNdc": "71800-059",
  "deaSchedule": null,
  "genericName": "GUAIFENESIN",
  "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": "GUAIFENESIN",
      "strength": "100 mg/5mL"
    }
  ],
  "applicationNumber": "M012",
  "marketingCategory": "OTC MONOGRAPH DRUG",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20250616",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "non-prescription",
  "harmonizedIdentifiers": {
    "nui": [
      "N0000193956",
      "N0000008867",
      "N0000009560"
    ],
    "unii": [
      "495W7451VQ"
    ],
    "rxcui": [
      "310604"
    ],
    "spl_set_id": [
      "1006906e-d6d7-4f49-92bf-3cb2d2cdbb16"
    ],
    "pharm_class_pe": [
      "Decreased Respiratory Secretion Viscosity [PE]",
      "Increased Respiratory Secretions [PE]"
    ],
    "pharm_class_epc": [
      "Expectorant [EPC]"
    ],
    "manufacturer_name": [
      "Innovida Pharmaeutique Corporation"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20261231"
}

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