{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "hydrocortisone and acetic acid hydrocortisone and acetic acid otic BENZETHONIUM CHLORIDE PROPYLENE GLYCOL PROPYLENE GLYCOL DIACETATE SODIUM ACETATE ACETIC ACID ACETIC ACID HYDROCORTISONE HYDROCORTISONE ANHYDROUS CITRIC ACID"
      ],
      "description": [
        "DESCRIPTION: Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.015%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are: Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Chemical Structure_Hydrocortisone"
      ],
      "clinical_pharmacology": [
        "CLINICAL PHARMACOLOGY: Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE: For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation."
      ],
      "contraindications": [
        "CONTRAINDICATIONS: Hypersensitivity to Hydrocortisone and Acetic Acid or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal."
      ],
      "warnings": [
        "WARNINGS: Discontinue promptly if sensitization or irritation occurs."
      ],
      "precautions": [
        "PRECAUTIONS: Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear. PEDIATRIC USE: Safety and effectiveness in pediatric patients below the age of 3 years have not been established."
      ],
      "pediatric_use": [
        "PEDIATRIC USE: Safety and effectiveness in pediatric patients below the age of 3 years have not been established."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS: Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-­800-FDA-1088 or www.fda.gov/medwatch ."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION: Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Hydrocortisone and Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal."
      ],
      "how_supplied": [
        "HOW SUPPLIED: Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 71656-064-10)."
      ],
      "spl_unclassified_section": [
        "STORAGE: Store at room temperature, 20°C to 25°C (68°F to 77°F). Keep container tightly closed. Rx only Distributed by: Saptalis Pharmaceuticals, LLC. Hauppauge, NY 11788 MADE IN USA May 2024-R3 PPM-0082"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Label",
        "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Carton"
      ],
      "set_id": "d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32",
      "id": "339e0417-4d1a-e168-e063-6294a90a50bb",
      "effective_time": "20250425",
      "version": "3",
      "openfda": {
        "application_number": [
          "NDA012770"
        ],
        "brand_name": [
          "hydrocortisone and acetic acid"
        ],
        "generic_name": [
          "HYDROCORTISONE AND ACETIC ACID OTIC"
        ],
        "manufacturer_name": [
          "Saptalis Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "71656-064"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "ACETIC ACID",
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "313786"
        ],
        "spl_id": [
          "339e0417-4d1a-e168-e063-6294a90a50bb"
        ],
        "spl_set_id": [
          "d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32"
        ],
        "package_ndc": [
          "71656-064-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "Q40Q9N063P",
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}