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United States · US · US:41520-301_b9b6767c-f3bf-4a95-9acd-13a0424d9c4b

careone childrens allergy relief

Orange BookUNIISPLATC R06AE

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

Identification

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

Packs · 1

  • ndc11
    4152030126
    1 BOTTLE in 1 CARTON (41520-301-26) / 118 mL in 1 BOTTLE

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": {
    "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": "41520-301_b9b6767c-f3bf-4a95-9acd-13a0424d9c4b",
  "productndc": "41520-301",
  "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": "careone childrens allergy relief",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20171009",
  "active_numerator_strength": "5"
}

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