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United States · US · US:68016-531_d2448d3f-a6f0-47c9-bf63-0a4bcdaf0ae4

Allergy relief-D

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerCHAIN DRUG CONSORTIUM,LLC
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6801653124
    24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (68016-531-24)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090922
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": "68016-531_d2448d3f-a6f0-47c9-bf63-0a4bcdaf0ae4",
  "productndc": "68016-531",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090922",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Allergy relief-D",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA090922",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20160817",
  "active_numerator_strength": "5; 120"
}

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