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United States · US · US:66715-9811_1b6c945f-5920-8869-e063-6294a90ad397

Zyrtec Allergy, Lil Drug Store

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerLil' Drug Store Products, Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6671598111
    1 POUCH in 1 CARTON (66715-9811-1) / 1 TABLET, FILM COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N019835
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": {
    "dc613bd5-70fd-1d9b-e053-2995a90a41cd": {
      "match": "brand_token",
      "title": "ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
      "spl_version": "9",
      "published_date": "2026-04-30"
    }
  },
  "productid": "66715-9811_1b6c945f-5920-8869-e063-6294a90ad397",
  "productndc": "66715-9811",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019835",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "006",
        "approval_date": "Nov 16, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Zyrtec Allergy, Lil Drug Store",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019835",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine Hydrochloride tablet, film coated",
  "start_marketing_date": "20240710",
  "active_numerator_strength": "10"
}

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