Leader 24HR Allergy Relief

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7000007251
1 BOTTLE in 1 CARTON (70000-0725-1) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
7000007252
1 BOTTLE in 1 CARTON (70000-0725-2) / 70 TABLET, FILM COATED in 1 BOTTLE
ndc11
7000007253
1 BOTTLE in 1 CARTON (70000-0725-3) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
7000007254
15 BLISTER PACK in 1 CARTON (70000-0725-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A212971

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": {
    "12971fb2-2314-4443-bf70-b7eb5859b148": {
      "match": "brand_token",
      "title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70000-0725_c82dd837-c3bd-4762-9b4c-d7ce25393a9b",
  "productndc": "70000-0725",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212971",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Feb 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Feb 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Leader 24HR Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212971",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fexofenadine hydrochloride",
  "start_marketing_date": "20250401",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code R06AX26.

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