Claritin Chewable Grape and Bubblegum

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBayer HealthCare LLC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1152301231
1 KIT in 1 CARTON (11523-0123-1)

Annotations

Orange Book

N021891

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "8e14b61f-faf6-43a8-a080-75f64514217a": {
      "match": "brand_token",
      "title": "CLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]",
      "spl_version": "13",
      "published_date": "2026-02-09"
    }
  },
  "productid": "11523-0123_4526df19-7a6e-0f19-e063-6394a90a3954",
  "productndc": "11523-0123",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021891",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 23, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Claritin Chewable Grape and Bubblegum",
  "active_ingred_unit": null,
  "application_number": "NDA021891",
  "marketing_category": "NDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20060823",
  "active_numerator_strength": null
}

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