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United States · US · US:53943-130_502476ab-e17d-bf5a-e063-6294a90a84fe

Allergy Relief

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerDISCOUNT DRUG MART, INC
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5394313013
    1 BOTTLE, PLASTIC in 1 CARTON (53943-130-13) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5394313017
    1 BOTTLE, PLASTIC in 1 CARTON (53943-130-17) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078862
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": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "53943-130_502476ab-e17d-bf5a-e063-6294a90a84fe",
  "productndc": "53943-130",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078862",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 19, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 19, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Feb 19, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Feb 19, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078862",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Tablets",
  "start_marketing_date": "20260520",
  "active_numerator_strength": "10"
}

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