Childrens Zyrtec Allergy

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5058072105
1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

N022155

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d",
  "productndc": "50580-721",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "022155",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Nov 16, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Childrens Zyrtec Allergy",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA022155",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20090120",
  "active_numerator_strength": "5"
}

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