CareOne Allergy Relief

Orange BookUNIISPLATC R06AX26

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmerican Sales Company

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4152022922
15 BLISTER PACK in 1 CARTON (41520-229-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4152022939
1 BOTTLE in 1 CARTON (41520-229-39) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
4152022995
1 BOTTLE in 1 CARTON (41520-229-95) / 45 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A076447

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": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-229_57501f04-ba3d-4e21-af64-60674a4c9256",
  "productndc": "41520-229",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076447",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Sep 1, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Sep 1, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Sep 1, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Apr 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Apr 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Apr 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "007",
        "approval_date": "Apr 13, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "008",
        "approval_date": "Apr 13, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "CareOne Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076447",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fexofenadine hcl",
  "start_marketing_date": "20161014",
  "active_numerator_strength": "180"
}

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