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United States · US · US:51316-801_93404a1d-ff78-4a5f-bf59-7323d78be195

Allergy Relief

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerCVS PHARMACY, INC
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131680130
    1 BOTTLE, PLASTIC in 1 BOX (51316-801-30) / 30 TABLET in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A211075
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": "51316-801_93404a1d-ff78-4a5f-bf59-7323d78be195",
  "productndc": "51316-801",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Oct 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCl",
  "start_marketing_date": "20230130",
  "active_numerator_strength": "180"
}

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