{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "DRx Choice Sore Throat Menthol Flavor Phenol PHENOL PHENOL FD&C GREEN NO. 3 D&C GREEN NO. 5 D&C YELLOW NO. 10 GLYCERIN WATER SUCRALOSE clear"
      ],
      "active_ingredient": [
        "Active ingredient Phenol 1.4%"
      ],
      "purpose": [
        "Purpose Oral pain reliever"
      ],
      "indications_and_usage": [
        "Uses For the temporarily relieves of occasional minor irritation, pain, sore mouth and sore throat."
      ],
      "warnings": [
        "Warnings Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor. When using this product, do not exceed recommended dosage. Stop use and ask a doctor or dentist if ▪ sore mouth symptoms do not improve in 7 days ▪ irritation, pain or redness persists or worsens ▪ swelling, rash or fever develops If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)."
      ],
      "when_using": [
        "When using this product, do not exceed recommended dosage."
      ],
      "stop_use": [
        "Stop use and ask a doctor or dentist if ▪ sore mouth symptoms do not improve in 7 days ▪ irritation, pain or redness persists or worsens ▪ swelling, rash or fever develops"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a doctor before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions ▪ Adults and children 12 year of age and older: Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out. Use every 2 hours or as directed by a doctor or dentist ▪ Children under 12 years of age: Should be supervised in use of this product. ▪ Children under 6 years of age : Ask a doctor or dentist"
      ],
      "storage_and_handling": [
        "Other information • Store at room temperature • Check expiration date before using."
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C Green #3, D&C Green #5, FD&C Yellow #10, flavor, glycerin, purified water, sucralose."
      ],
      "questions": [
        "Questions or comments? 1-866-467-2748"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel DRx Choice ® NDC# 68163-307-06 *Compare to the active ingredient in Chloraseptic ® Sore throat spray Phenol/Oral Pain Reliever • Fast Acting • Numbs on Contact SUGAR-FREE ASPIRIN-FREE Menthol Flavor Naturally and Artificially Flavored 6 FL OZ. (177 mL) *This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®. TAMPER EVIDENT: Do not use if imprinted shrink band is broken or torn. DRx Choice Sore Throat Phenol"
      ],
      "set_id": "e3269b12-5c05-45a6-81f2-65d9f016c3aa",
      "id": "c40b4866-1eb6-4805-9d0c-0666575e737b",
      "effective_time": "20260908",
      "version": "5",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "DRx Choice Sore Throat Menthol Flavor"
        ],
        "generic_name": [
          "PHENOL"
        ],
        "manufacturer_name": [
          "RARITAN PHARMACEUTICALS INC"
        ],
        "product_ndc": [
          "68163-307"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PHENOL"
        ],
        "rxcui": [
          "198776"
        ],
        "spl_id": [
          "c40b4866-1eb6-4805-9d0c-0666575e737b"
        ],
        "spl_set_id": [
          "e3269b12-5c05-45a6-81f2-65d9f016c3aa"
        ],
        "package_ndc": [
          "68163-307-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368163703078"
        ],
        "unii": [
          "339NCG44TV"
        ]
      }
    }
  ]
}