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United States · US · US:41520-716_567de4c6-c106-4597-9e1a-f43fbb1592d6

careone childrens allergy relief

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 2

  • ndc11
    4152071601
    20 BLISTER PACK in 1 CARTON (41520-716-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
  • ndc11
    4152071639
    30 BLISTER PACK in 1 CARTON (41520-716-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210033
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": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-716_567de4c6-c106-4597-9e1a-f43fbb1592d6",
  "productndc": "41520-716",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "210033",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "careone childrens allergy relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210033",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loratadine",
  "start_marketing_date": "20190716",
  "active_numerator_strength": "5"
}

Related drugs

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