Zyrtec

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dc613bd5-70fd-1d9b-e053-2995a90a41cd": {
      "match": "brand_token",
      "title": "ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
      "spl_version": "9",
      "published_date": "2026-04-30"
    }
  },
  "productid": "50580-753_506ace58-15cc-77b4-e063-6394a90a0813",
  "productndc": "50580-753",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "021621",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "007",
        "approval_date": "Nov 30, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Zyrtec",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021621",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20220620",
  "active_numerator_strength": "10"
}