{
  "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": [
        "Orajel Toothache Rinse Benzyl Alcohol, Zinc Chloride METHYL SALICYLATE POLOXAMER 338 POLYSORBATE 20 SODIUM BENZOATE SORBITOL FD&C BLUE NO. 1 CALCIUM DISODIUM PYROPHOSPHATE MENTHOL, UNSPECIFIED FORM POTASSIUM SODIUM SACCHARATE SODIUM PYROPHOSPHATE WATER ALCOHOL BENZYL ALCOHOL BENZYL ALCOHOL ZINC CHLORIDE ZINC CATION"
      ],
      "active_ingredient": [
        "Benzyl Alcohol 0.27% Zinc Chloride 0.15%"
      ],
      "purpose": [
        "Oral pain reliever Oral astringent"
      ],
      "indications_and_usage": [
        "Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat"
      ],
      "warnings": [
        "Warnings Do not use this product for more than 7 days unless directed by a dentist or healthcare provider"
      ],
      "when_using": [
        "When using this product • do not swallow • do not exceed recommended dosage"
      ],
      "stop_use": [
        "Stop use and see your physician promptly if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "dosage_and_administration": [
        "Directions • remove imprinted safety seal from bottle cap • to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age or over: Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider Children under 12 years of age: Should be supervised in the use of this product Children under 2 years of age: Consult a dentist or healthcare provider Other Information • cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients alcohol (4.1% by volume), blue 1, disodium pyrophosphate, menthol, methyl salicylate, poloxamer 338, polysorbate 20, sodium benzoate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, water"
      ],
      "questions": [
        "Questions or comments calls us at 800 952 5080 Monday through Friday 9 to 5 ET or visit our website at www orajel com"
      ],
      "package_label_principal_display_panel": [
        "#1 ORAL PAIN RELIEVER BRAND FOR TOOTHACHE NON-NUMBING RELIEF! Orajel™ For TOOTHACHE Analgesic & Astringent Rinse Provides All-Over Oral Pain Relief Soothes Irritated Gums Cleans Affected Area Kills Odor-Causing Bacteria Soothing Mint Rinse ORAL PAIN RELIEVER/ ASTRINGENT 16 FL OZ (473.2 mL) DA2011186_OJLBF-43001-02_72013520"
      ],
      "set_id": "41709710-5392-3119-e054-00144ff88e88",
      "id": "27e7c3b6-5f9a-a7f3-e063-6394a90a02a7",
      "effective_time": "20241127",
      "version": "8",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Orajel Toothache Rinse"
        ],
        "generic_name": [
          "BENZYL ALCOHOL, ZINC CHLORIDE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-764"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZYL ALCOHOL",
          "ZINC CHLORIDE"
        ],
        "rxcui": [
          "1865199"
        ],
        "spl_id": [
          "27e7c3b6-5f9a-a7f3-e063-6394a90a02a7"
        ],
        "spl_set_id": [
          "41709710-5392-3119-e054-00144ff88e88"
        ],
        "package_ndc": [
          "10237-764-16",
          "10237-764-08"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000181811"
        ],
        "pharm_class_epc": [
          "Pediculicide [EPC]"
        ],
        "unii": [
          "LKG8494WBH",
          "86Q357L16B"
        ]
      }
    }
  ]
}