{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Plan B One-Step levonorgestrel LEVONORGESTREL LEVONORGESTREL SILICON DIOXIDE STARCH, POTATO MAGNESIUM STEARATE TALC STARCH, CORN LACTOSE MONOHYDRATE G00 Plan B One-Step levonorgestrel LEVONORGESTREL LEVONORGESTREL SILICON DIOXIDE STARCH, POTATO MAGNESIUM STEARATE TALC STARCH, CORN LACTOSE MONOHYDRATE G00"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: Foundation Consumer Healthcare, LLC. (FCH) Pittsburgh, PA 15205"
      ],
      "active_ingredient": [
        "Active ingredient Levonorgestrel 1.5 mg"
      ],
      "purpose": [
        "Purpose Emergency contraceptive"
      ],
      "indications_and_usage": [
        "Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)"
      ],
      "warnings": [
        "Warnings Allergy alert Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) alert This product does not protect against HIV/AIDS or other STDs Do not use if you are already pregnant (because it will not work) for regular birth control Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel. When using this product you may have menstrual changes tiredness breast pain nausea headache vomiting lower stomach (abdominal) pain dizziness Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away."
      ],
      "do_not_use": [
        "Do not use if you are already pregnant (because it will not work) for regular birth control"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel."
      ],
      "when_using": [
        "When using this product you may have menstrual changes tiredness breast pain nausea headache vomiting lower stomach (abdominal) pain dizziness"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away."
      ],
      "dosage_and_administration": [
        "Directions take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose"
      ],
      "storage_and_handling": [
        "Other information read the instructions, warnings and enclosed product leaflet before use do not use if carton is open or tear strip is removed or blister seal is broken or missing store at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc"
      ],
      "questions": [
        "Questions? Call 1-800-330-1271 or visit www.PlanBOneStep.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-162-88 NDC 69536-162-88 This item is electronically protected Plan B One-Step ® levonorgestrel 1.5 mg emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. One Tablet. One Step. 1 Tablet Levonorgestrel 1.5 mg PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-162-88",
        "PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-146-19 FOR CLINIC USE ONLY. NOT FOR RETAIL SALE. NDC 69536-146-19 Plan B One-Step ® levonorgestrel 1.5 mg emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. One Tablet. One Step. 1 Tablet Levonorgestrel 1.5 mg PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-146-19"
      ],
      "set_id": "6ce6b40e-14ac-47bd-a648-ddf9e452e559",
      "id": "a0190797-2a39-47be-803b-bec877085166",
      "effective_time": "20230131",
      "version": "5",
      "openfda": {
        "application_number": [
          "NDA021998"
        ],
        "brand_name": [
          "Plan B One-Step"
        ],
        "generic_name": [
          "LEVONORGESTREL"
        ],
        "manufacturer_name": [
          "Foundation Consumer Healthcare LLC"
        ],
        "product_ndc": [
          "69536-146",
          "69536-162"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVONORGESTREL"
        ],
        "rxcui": [
          "483325",
          "858079"
        ],
        "spl_id": [
          "a0190797-2a39-47be-803b-bec877085166"
        ],
        "spl_set_id": [
          "6ce6b40e-14ac-47bd-a648-ddf9e452e559"
        ],
        "package_ndc": [
          "69536-162-88",
          "69536-162-99",
          "69536-146-19"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369536146195",
          "0369536162881"
        ],
        "nui": [
          "N0000175830",
          "M0447349",
          "N0000175602",
          "N0000175832"
        ],
        "pharm_class_pe": [
          "Inhibit Ovum Fertilization [PE]"
        ],
        "pharm_class_cs": [
          "Progesterone Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Progestin [EPC]",
          "Progestin-containing Intrauterine System [EPC]"
        ],
        "unii": [
          "5W7SIA7YZW"
        ]
      }
    }
  ]
}