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United States · US · US:53117-414_2951457f-e466-43c5-a39e-274c36098613

Allergy Relief

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerFirst Aid Direct
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5311741485
    2 BLISTER PACK in 1 CARTON (53117-414-85) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210722
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": {
    "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": "53117-414_2951457f-e466-43c5-a39e-274c36098613",
  "productndc": "53117-414",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210722",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210722",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine 10mg",
  "start_marketing_date": "20201111",
  "active_numerator_strength": "10"
}

Related drugs

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