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United States · US · US:63981-612_39dbaef4-0637-4ba0-9af1-ccb87eb17daf

kirkland signature allerclear

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerCostco Wholesale Company
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6398161288
    1 BOTTLE in 1 PACKAGE (63981-612-88) / 365 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076301
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AJO3BO7QN",
    "rxcui": "28889",
    "inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
    "display_name": "LORATADINE",
    "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": "63981-612_39dbaef4-0637-4ba0-9af1-ccb87eb17daf",
  "productndc": "63981-612",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076301",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 25, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "kirkland signature allerclear",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076301",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20101015",
  "active_numerator_strength": "10"
}

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