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United States · US · US:63981-475_fcdbe753-6a33-4c46-acfe-3ead668364ec

Kirkland Signature Childrens Aller Tec

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerCostco Wholesale Company
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6398147543
    2 BOTTLE in 1 CARTON (63981-475-43) / 240 mL in 1 BOTTLE (63981-475-34)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A204226
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": {
    "bf120a48-cc29-4f40-b70d-415868ac9d3e": {
      "match": "brand_token",
      "title": "KIRKLAND SIGNATURE ALLER FLO (FLUTICASONE PROPIONATE) SPRAY, METERED [COSTCO WHOLESALE COMPANY]",
      "spl_version": "8",
      "published_date": "2026-01-14"
    }
  },
  "productid": "63981-475_fcdbe753-6a33-4c46-acfe-3ead668364ec",
  "productndc": "63981-475",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "204226",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 9, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Kirkland Signature Childrens Aller Tec",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20160708",
  "active_numerator_strength": "5"
}

Related drugs

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