Back to search
🇺🇸

United States · US · US:70000-0053_ece56087-7def-0eb9-13d3-b187763b7f7b

Eye Allergy Itch Relief

Orange BookUNIISPLATC R01AC08

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

Identification

ManufacturerCARDINAL HEALTH 110, LLC. DBA LEADER
CountryUS (United States)
ATC codeR01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000000531
    1 BOTTLE, DROPPER in 1 CARTON (70000-0053-1) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A209752
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2XG66W44KF",
    "rxcui": "236599",
    "inchikey": "HVRLZEKDTUEKQH-NOILCQHBSA-N",
    "display_name": "OLOPATADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "52c62397-58f1-d34d-e063-6294a90a6faf": {
      "match": "brand_token",
      "title": "EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "70000-0053_ece56087-7def-0eb9-13d3-b187763b7f7b",
  "productndc": "70000-0053",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "209752",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.2% BASE",
        "product_no": "001",
        "approval_date": "May 20, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Eye Allergy Itch Relief",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209752",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine HCl",
  "start_marketing_date": "20210115",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code R01AC08.

Access this data programmatically

Query Eye Allergy Itch Relief and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.