All Day Allergy Relief

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerCHAIN DRUG MARKETING ASSOCIATION INC.

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6386843325
1 BOTTLE, PLASTIC in 1 BOX (63868-433-25) / 25 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

N022429

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": {
    "8889af37-8345-4358-994d-7d8b847f4874": {
      "match": "brand_token",
      "title": "ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [HYVEE INC]",
      "spl_version": "6",
      "published_date": "2026-05-13"
    }
  },
  "productid": "63868-433_f0fec7d5-f90e-753c-e053-2a95a90a3aeb",
  "productndc": "63868-433",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "022429",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jul 23, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "All Day Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022429",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20190125",
  "active_numerator_strength": "10"
}

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