{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Zolidyne Pyrithione Zinc PYRITHIONE ZINC PYRITHIONE ZINC AMMONIUM LAURYL SULFATE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE GLYCOL DISTEARATE FD&C BLUE NO. 1 GLYCERIN HYPROMELLOSE, UNSPECIFIED LAURIC ISOPROPANOLAMIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SODIUM LAURETH-3 SULFATE WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Pyrithione, 2%"
      ],
      "purpose": [
        "Purpose Antidandruff, Seborrheic Dermatitis"
      ],
      "indications_and_usage": [
        "Uses A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis."
      ],
      "warnings": [
        "Warnings For external use only Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water If condition worsens or does not improve after regular use of this product as directed, consult a doctor If condition covers a large area of the body, consult your doctor before using this product Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes For best results, use at least twice a week or as directed by your doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 200 ml Tube Label DERMA TOPIX zolidyne shampoo Zinc Pyrithione, 2% Net 6.7 fl. oz. (200 ml.) Topix Pharmaceuticals, Inc. N. Amityville, NY 11701 PRINCIPAL DISPLAY PANEL - 200 ml Tube Label"
      ],
      "set_id": "6d5eaecc-a3a1-4739-ae5b-66df4a15cd21",
      "id": "34c76824-3047-41a6-805a-a17e63e0c019",
      "effective_time": "20191120",
      "version": "7",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Zolidyne"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "Topiderm, Inc."
        ],
        "product_ndc": [
          "51326-203"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "244458"
        ],
        "spl_id": [
          "34c76824-3047-41a6-805a-a17e63e0c019"
        ],
        "spl_set_id": [
          "6d5eaecc-a3a1-4739-ae5b-66df4a15cd21"
        ],
        "package_ndc": [
          "51326-203-67"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0358211203674"
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}