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United States · US · US:68788-4023_0827643a-29b8-487a-a158-28976d672d4d

Good Sense all day allergy

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerPreferred Pharmaceuticals Inc
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6878840233
    30 TABLET, FILM COATED in 1 BOTTLE (68788-4023-3)
  • ndc11
    6878840236
    60 TABLET, FILM COATED in 1 BOTTLE (68788-4023-6)
  • ndc11
    6878840239
    90 TABLET, FILM COATED in 1 BOTTLE (68788-4023-9)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078336
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": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68788-4023_0827643a-29b8-487a-a158-28976d672d4d",
  "productndc": "68788-4023",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078336",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Dec 27, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Good Sense all day allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078336",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20250912",
  "active_numerator_strength": "10"
}

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