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United States · US · US:51660-726_10b0df2b-89b6-c4f8-e063-6294a90a68ed

DYE-FREE CHILDRENS LORATADINE

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerOhm Laboratories Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166072630
    3 BLISTER PACK in 1 CARTON (51660-726-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • ndc11
    5166072661
    6 BLISTER PACK in 1 CARTON (51660-726-61) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210088
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": {
    "48744daa-7079-283d-e063-6394a90a2c9a": {
      "match": "brand_token",
      "title": "DYE-FREE LORATADINE (LORATADINE) TABLET, CHEWABLE [OHM LABORATORIES INC.]",
      "spl_version": "2",
      "published_date": "2026-05-21"
    }
  },
  "productid": "51660-726_10b0df2b-89b6-c4f8-e063-6294a90a68ed",
  "productndc": "51660-726",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "210088",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 25, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "DYE-FREE CHILDRENS LORATADINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210088",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20240315",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AX13.

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