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United States · US · US:70000-0504_ae900734-0351-4a74-98a0-4af543e1882d

Leader Allergy Relief D12

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7000005041
    10 BLISTER PACK in 1 CARTON (70000-0504-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    7000005042
    20 BLISTER PACK in 1 CARTON (70000-0504-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    7000005043
    30 BLISTER PACK in 1 CARTON (70000-0504-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076050
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AJO3BO7QN",
    "rxcui": "28889",
    "inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
    "display_name": "LORATADINE",
    "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": "70000-0504_ae900734-0351-4a74-98a0-4af543e1882d",
  "productndc": "70000-0504",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "Leader Allergy Relief D12",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loratadine, Pseudoephedrine sulfate",
  "start_marketing_date": "20200109",
  "active_numerator_strength": "5; 120"
}

Related drugs

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