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United States · US · US:63981-723_24d75860-d636-416a-b89f-4b503c526802

kirkland signature allerclear d 12 hr

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerCostco Wholesale Company
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6398172365
    30 BLISTER PACK in 1 CARTON (63981-723-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076050
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": "63981-723_24d75860-d636-416a-b89f-4b503c526802",
  "productndc": "63981-723",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "kirkland signature allerclear d 12 hr",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loratadine, Pseudoephedrine sulfate",
  "start_marketing_date": "20180507",
  "active_numerator_strength": "5; 120"
}

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