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United States · US · US:50580-730_40cb0507-49ef-8320-e063-6294a90ae39f

Childrens Zyrtec

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5058073001
    1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) / 30 mL in 1 BOTTLE, PLASTIC
  • ndc11
    5058073005
    1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05) / 118 mL in 1 BOTTLE, PLASTIC
  • ndc11
    5058073006
    2 CARTON in 1 PACKAGE (50580-730-06) / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
  • ndc11
    5058073017
    3 TRAY in 1 PACKAGE (50580-730-17) / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLE
  • ndc11
    5058073018
    2 CARTON in 1 PACKAGE (50580-730-18) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
  • ndc11
    5058073019
    1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19) / 240 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": "50580-730_40cb0507-49ef-8320-e063-6294a90ae39f",
  "productndc": "50580-730",
  "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",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA022155",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20090601",
  "active_numerator_strength": "5"
}

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