{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CETYL ALCOHOL GLYCERYL STEARATE SE LAURETH-23 METHYLPARABEN MINERAL OIL PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN STEARIC ACID STEARYL ALCOHOL WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION"
      ],
      "active_ingredient": [
        "Active Ingredients Diphenhydramine hydrochloride 2% Zinc acetate 0.1%"
      ],
      "purpose": [
        "Purpose Topical analgesic Skin protectant"
      ],
      "indications_and_usage": [
        "for temprary relief from pain and itching associated Uses with insect bites , sunburn and mior skin irritations. Dries the oozing and weeping of poison: •ivy •oak •sumac"
      ],
      "warnings": [
        "Warnings . For external use only Do not use •avoid contact with eyes When using this product Ask a doctor before use •on chicken pox •on measles Stop use and ask a doctor if over large areas of the body with any other product containing diphenhydramine including those taken orally symptoms last for more than 7 days the condition gets worse symptoms clear up and then occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        ". If swallowed, get medical help Keep out of reach of children or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions •for adults and children over 2 years of age: apply to affected area not more than 3 to 4 times daily •children under 2 years of age: ask a doctor before use"
      ],
      "other_safety_information": [
        "store at room temperature 59° - 86° F Other information (15° - 30° C)."
      ],
      "inactive_ingredient": [
        "cetyl alcohol, glyceryl stearate se, Inactive ingredients laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearic alcohol, water"
      ],
      "questions": [
        "1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?"
      ],
      "package_label_principal_display_panel": [
        "label image description"
      ],
      "set_id": "fde2069b-344e-46da-bb95-c5113e0f35d6",
      "id": "08a16eed-ba21-b1fa-e063-6294a90a6615",
      "effective_time": "20231026",
      "version": "4",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Family Wellness"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE"
        ],
        "manufacturer_name": [
          "FRONT PHARMACEUTICAL PLC"
        ],
        "product_ndc": [
          "69571-005"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1087026"
        ],
        "spl_id": [
          "08a16eed-ba21-b1fa-e063-6294a90a6615"
        ],
        "spl_set_id": [
          "fde2069b-344e-46da-bb95-c5113e0f35d6"
        ],
        "package_ndc": [
          "69571-005-01",
          "69571-005-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0032251071829"
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}