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United States · US · US:0363-3311_1d57d104-36ee-4210-ac65-4828d19ccab9

childrens allergy relief

Orange BookUNIISPLATC R06AE

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

Identification

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

Packs · 2

  • ndc11
    0363331126
    1 BOTTLE in 1 CARTON (0363-3311-26) / 120 mL in 1 BOTTLE
  • ndc11
    0363331134
    1 BOTTLE in 1 CARTON (0363-3311-34) / 240 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": "0363-3311_1d57d104-36ee-4210-ac65-4828d19ccab9",
  "productndc": "0363-3311",
  "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 allergy relief",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20220805",
  "active_numerator_strength": "5"
}

Related drugs

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