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United States · US · US:65785-125_445cc5b0-291c-a344-e063-6394a90a0298

ULINE Eyewash

Orange BookUNIISPL

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

Identification

ManufacturerNiagara Pharmaceuticals Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6578512501
    473 mL in 1 BOTTLE, UNIT-DOSE (65785-125-01)
  • ndc11
    6578512502
    946 mL in 1 BOTTLE, UNIT-DOSE (65785-125-02)

Annotations

UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
N022305
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "059QF0KO0R",
    "rxcui": "11295",
    "inchikey": "XLYOFNOQVPJJNP-UHFFFAOYSA-N",
    "display_name": "WATER",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "2d7f22d2-320b-6af1-e063-6294a90addc6": {
      "match": "brand_token",
      "title": "ULINE EYEWASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS INC.]",
      "spl_version": "4",
      "published_date": "2025-11-25"
    }
  },
  "productid": "65785-125_445cc5b0-291c-a344-e063-6394a90a0298",
  "productndc": "65785-125",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "022305",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "98.3%",
        "product_no": "001",
        "approval_date": "Sep 1, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "WATER",
  "proprietary_name": "ULINE Eyewash",
  "active_ingred_unit": "mL/473mL",
  "application_number": "NDA022305",
  "marketing_category": "NDA",
  "nonproprietary_name": "Eyewash",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "465"
}

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