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United States · US · US:36800-180_6fe07c0a-a5f6-45dd-b67e-ea214d3870e3

top care all day allergy

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3680018009
    1 BOTTLE in 1 PACKAGE (36800-180-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    3680018063
    1 BOTTLE in 1 PACKAGE (36800-180-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A207235
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": {
    "8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c": {
      "match": "brand_token",
      "title": "TOP CARE ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [TOPCO ASSOC. LLC]",
      "spl_version": "9",
      "published_date": "2025-11-18"
    }
  },
  "productid": "36800-180_6fe07c0a-a5f6-45dd-b67e-ea214d3870e3",
  "productndc": "36800-180",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "207235",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 12, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "top care all day allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hydrochloride",
  "start_marketing_date": "20200606",
  "active_numerator_strength": "10"
}

Related drugs

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