BERKLEY AND JENSEN ALL DAY ALLERGY

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerBJWC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6839140001
2 BOTTLE in 1 PACKAGE (68391-400-01) / 200 TABLET, FILM COATED in 1 BOTTLE (68391-400-00)

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": {
    "cda57e42-6106-46ee-82d1-479a692ee5bb": {
      "match": "brand_token",
      "title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68391-400_09c3300a-a96f-4967-aa1d-85b6e9fd5798",
  "productndc": "68391-400",
  "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": "BERKLEY AND JENSEN ALL DAY ALLERGY",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078336",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20250904",
  "active_numerator_strength": "10"
}

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