{
  "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",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Hemorrhoidal cocoa butter Hemorrhoidal METHYLPARABEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) COCOA BUTTER COCOA BUTTER PROPYLPARABEN"
      ],
      "active_ingredient": [
        "Drug Facts : Active Ingredients (in each suppository) : Cocoa butter 88.44% Phenylephrine Hydrochloride 0.25%"
      ],
      "purpose": [
        "Purpose Protectant Vasoconstrictor"
      ],
      "indications_and_usage": [
        "Uses: • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritatedanorectal surface to help make bowel movements less painful."
      ],
      "warnings": [
        "Warnings: For rectal use only"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of prostate gland unless directed by a doctor"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression."
      ],
      "when_using": [
        "When using this product: • do not exceed the recommended daily dosage unless directed by a doctor • children under 12 years of age: ask a doctor"
      ],
      "stop_use": [
        "Stop use and ask doctor if • bleeding occurs • condition worsens or does not improve within 7 days"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"
      ],
      "storage_and_handling": [
        "Other information: store at 20° - 25°C (68° - 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients: methylparaben, propylparaben, topical starch"
      ],
      "dosage_and_administration": [
        "Directions: • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: • hold suppository with rounded end • see illustrations; carefully separate foil tabs by inserting tip of fingernail at end marked “peel down” • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository • remove exposed suppository from wrapper • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement."
      ],
      "intended_use_of_the_device": [
        "Shrinks Swollen Tissue • Reduces internal swelling, soothes & protects • Gives prompt relief from the painful burning, itching & discomfort from hemorrhoids on a temporary basis"
      ],
      "package_label_principal_display_panel": [
        "Suppositories 24count"
      ],
      "set_id": "03b159b0-b960-b38d-e063-6394a90a9462",
      "id": "2beb0548-764d-eb34-e063-6294a90a64d9",
      "effective_time": "20250117",
      "version": "2",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Hemorrhoidal cocoa butter"
        ],
        "generic_name": [
          "HEMORRHOIDAL"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "13709-323"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "COCOA BUTTER",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1438497"
        ],
        "spl_id": [
          "2beb0548-764d-eb34-e063-6294a90a64d9"
        ],
        "spl_set_id": [
          "03b159b0-b960-b38d-e063-6394a90a9462"
        ],
        "package_ndc": [
          "13709-323-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0705928160057"
        ],
        "unii": [
          "512OYT1CRR",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}