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United States · US · US:41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4

12 hour allergy d

Orange BookUNIISPLATC R06AE

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

Identification

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

Packs · 2

  • ndc11
    4125072853
    12 BLISTER PACK in 1 CARTON (41250-728-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    4125072862
    24 BLISTER PACK in 1 CARTON (41250-728-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210719
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": {
    "d63fff6c-a1cd-4636-b1d3-ae83be40c3f7": {
      "match": "brand_token",
      "title": "12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
      "spl_version": "2",
      "published_date": "2026-04-24"
    }
  },
  "productid": "41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4",
  "productndc": "41250-728",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210719",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "12 hour allergy d",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA210719",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hydrochloride, pseudoephedrine hydrochloride",
  "start_marketing_date": "20200407",
  "active_numerator_strength": "5; 120"
}

Related drugs

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