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United States · US · US:70677-0149_e4c85780-7cb5-b55c-e053-2995a90a0314

CHILDRENS ALLERGY RELIEF

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerStrategic Sourcing Services
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7067701491
    1 BOTTLE in 1 CARTON (70677-0149-1) / 118 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210622
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": "70677-0149_e4c85780-7cb5-b55c-e053-2995a90a0314",
  "productndc": "70677-0149",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "210622",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 13, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "CHILDRENS ALLERGY RELIEF",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210622",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hydrochloride",
  "start_marketing_date": "20220721",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code R06AE.

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