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United States · US · US:11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70

Children Claritin

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerBayer HealthCare LLC.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    1152343601
    1 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLE
  • ndc11
    1152343602
    1 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLE
  • ndc11
    1152343603
    1 BOTTLE in 1 CARTON (11523-4360-3) / 150 mL in 1 BOTTLE
  • ndc11
    1152343604
    1 BOTTLE in 1 CARTON (11523-4360-4) / 30 mL in 1 BOTTLE
  • ndc11
    1152343605
    1 BOTTLE in 1 CARTON (11523-4360-5) / 240 mL in 1 BOTTLE
  • ndc11
    1152343606
    1 BOTTLE in 1 CARTON (11523-4360-6) / 180 mL in 1 BOTTLE
  • ndc11
    1152343607
    2 BOTTLE in 1 CARTON (11523-4360-7) / 180 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
N020641
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": {
    "a26c3515-4a24-4988-b9bb-813420b15630": {
      "match": "brand_token",
      "title": "CHILDREN ALLERGY (FEXOFENADINE HCL) SUSPENSION [H E B]",
      "spl_version": "3",
      "published_date": "2026-05-13"
    }
  },
  "productid": "11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70",
  "productndc": "11523-4360",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "020641",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "002",
        "approval_date": "Nov 27, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Nov 19, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Children Claritin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA020641",
  "marketing_category": "NDA",
  "nonproprietary_name": "loratadine",
  "start_marketing_date": "20150526",
  "active_numerator_strength": "5"
}

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