{
  "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": "2026-06-03",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "SECONDARY NUMB Lidocaine Phenylephrine Gel LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE AMINOMETHYLPROPANOL WATER BENZYL ALCOHOL CAPRYLYL GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PHENOXYETHANOL PROPYLENE GLYCOL LIDOCAINE LIDOCAINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients (w/w) Lidocaine 5% Phenylephrine HCL 0.25% Purpose Local Anesthetic Vaso Constrictor"
      ],
      "purpose": [
        "Purpose Local Anesthetic Vaso Constrictor"
      ],
      "indications_and_usage": [
        "Uses • Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids"
      ],
      "warnings": [
        "Warnings For external use only Do not use if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination Ask a doctor before use if you are • presently taking medicine for high blood pressure or depression When using this product • do not put it into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic reaction to product occurs. Keep out of reach of children. If swallowed, call poison control centre or get medical help right away"
      ],
      "do_not_use": [
        "Do not use if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you are • presently taking medicine for high blood pressure or depression"
      ],
      "when_using": [
        "When using this product • do not put it into the rectum by using fingers or any mechanical device or applicator"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic reaction to product occurs."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, call poison control centre or get medical help right away"
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol"
      ],
      "questions": [
        "Questions? 1-844-782-2387"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "0f13f7b5-e3b1-451e-a6d6-e7e15bd04443",
      "id": "0976eff9-48c6-1669-e063-6394a90a8240",
      "effective_time": "20231106",
      "version": "2",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "SECONDARY NUMB Lidocaine Phenylephrine Gel"
        ],
        "generic_name": [
          "LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "LALANI Rx Consulting, Inc."
        ],
        "product_ndc": [
          "83120-378"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "2621576"
        ],
        "spl_id": [
          "0976eff9-48c6-1669-e063-6394a90a8240"
        ],
        "spl_set_id": [
          "0f13f7b5-e3b1-451e-a6d6-e7e15bd04443"
        ],
        "package_ndc": [
          "83120-378-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0860008622303"
        ],
        "nui": [
          "N0000175682",
          "M0000897",
          "N0000175426",
          "N0000175976"
        ],
        "pharm_class_epc": [
          "Amide Local Anesthetic [EPC]",
          "Antiarrhythmic [EPC]"
        ],
        "pharm_class_cs": [
          "Amides [CS]"
        ],
        "pharm_class_pe": [
          "Local Anesthesia [PE]"
        ],
        "unii": [
          "98PI200987",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}