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United States · US · US:11822-7388_0855522f-2405-be3c-f917-1eee93ea396a

Allergy and Congestion

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerRite Aid Corporation
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1182273885
    4 BLISTER PACK in 1 CARTON (11822-7388-5) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A076667
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2S068B75ZU",
    "rxcui": "236474",
    "inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
    "display_name": "FEXOFENADINE 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": "11822-7388_0855522f-2405-be3c-f917-1eee93ea396a",
  "productndc": "11822-7388",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;120MG",
        "product_no": "001",
        "approval_date": "Nov 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Allergy and Congestion",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCl and Pseudoephedrine HCI",
  "start_marketing_date": "20190719",
  "active_numerator_strength": "60; 120"
}

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