{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-02",
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    {
      "spl_product_data_elements": [
        "Probentra Probiotic Dietary Supplement Capsules LACTOBACILLUS ACIDOPHILUS LA 14 LACTOBACILLUS ACIDOPHILUS LA 14 BIFIDOBACTERIUM ANIMALIS LACTIS BL04 BIFIDOBACTERIUM ANIMALIS LACTIS BL04 LACTIPLANTIBACILLUS PLANTARUM LACTIPLANTIBACILLUS PLANTARUM LACTICASEIBACILLUS PARACASEI LPC-37 LACTICASEIBACILLUS PARACASEI LPC-37 LESSONIA NIGRESCENS LESSONIA NIGRESCENS BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES HYPROMELLOSE, UNSPECIFIED MALTODEXTRIN LEUCINE"
      ],
      "spl_unclassified_section": [
        ""
      ],
      "description": [
        "DESCRIPTION Probentra™ is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and maintain normal intestinal flora. Each serving (two capsules) delivers 40 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide and fructooligosaccharide (FOS). The proprietary probiotic blend includes: Lactobacillus acidophilus (La-14®) Bifidobacterium lactis (Bl-04®) Lactobacillus plantarum (Lp-115®) Lactobacillus paracasei (Lpc-37®) The formulation utilizes MAKTrek® Bi-Pass Technology to support probiotic viability during gastrointestinal transit. Probentra™ is intended for use under the supervision of a licensed healthcare practitioner."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Probentra™ is indicated as a probiotic dietary supplement to support digestive health and promote balance of normal intestinal microflora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan. (Notice: no disease treatment claims — this keeps you clean in Rx dietary supplement lane.)"
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Adults: Take two (2) capsules once daily, or as directed by a licensed healthcare practitioner."
      ],
      "contraindications": [
        "CONTRAINDICATIONS Probentra™ is contraindicated in individuals with known hypersensitivity to any of its ingredients."
      ],
      "warnings_and_cautions": [
        "WARNINGS AND PRECAUTIONS If pregnant, nursing, or attempting to conceive, consult a licensed healthcare professional prior to use. Keep out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. In case of accidental overdose, call a physician or poison control center immediately."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS Probiotic supplementation may occasionally result in mild gastrointestinal symptoms such as bloating, gas, or abdominal discomfort. If adverse reactions occur, discontinue use and consult a healthcare professional."
      ],
      "how_supplied": [
        "HOW SUPPLIED Probentra™ (NDC 85477-712-30) is supplied in bottles of 30 capsules."
      ],
      "storage_and_handling": [
        "STORAGE Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F). Protect from excessive heat, moisture, and light."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel 85477-712-30 Probentra 40 Billion CFU 30 Capsules Dispensed by Prescription 85477-712-30 Probentra 40 Billion CFU 30 Capsules Dispensed by Prescription"
      ],
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      "id": "e357f4a7-006b-4dcf-8f8c-8157f5f817ef",
      "effective_time": "20260225",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Probentra"
        ],
        "generic_name": [
          "PROBIOTIC DIETARY SUPPLEMENT CAPSULES"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-712"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES",
          "BIFIDOBACTERIUM ANIMALIS LACTIS BL04",
          "LACTICASEIBACILLUS PARACASEI LPC-37",
          "LACTIPLANTIBACILLUS PLANTARUM",
          "LACTOBACILLUS ACIDOPHILUS LA 14",
          "LESSONIA NIGRESCENS"
        ],
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        "package_ndc": [
          "85477-712-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "N2UDM48ZD6",
          "K1YRS2QLN2",
          "GXW9U52VV9",
          "QFC21096ON",
          "D4S8K64J5Z",
          "HTV58LVI9P"
        ]
      }
    }
  ]
}