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United States · US · US:41250-475_6b615779-697e-49e5-92f0-96be91b549b8

Childrens 24 Hour Allergy

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerMeijer Distribution Inc
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4125047500
    1 BOTTLE in 1 CARTON (41250-475-00) / 120 mL in 1 BOTTLE
  • ndc11
    4125047526
    1 BOTTLE in 1 CARTON (41250-475-26) / 118 mL in 1 BOTTLE
  • ndc11
    4125047534
    1 BOTTLE in 1 CARTON (41250-475-34) / 236 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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "41250-475_6b615779-697e-49e5-92f0-96be91b549b8",
  "productndc": "41250-475",
  "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": "Childrens 24 Hour Allergy",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20151202",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AE.

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