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United States · US · US:78641-786_c4f783d3-b047-ab39-e053-2995a90ab6f3

Eyewash

Orange BookUNIISPL

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

Identification

ManufacturerGlobal Equipment Company
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7864178667
    473 mL in 1 BOTTLE, UNIT-DOSE (78641-786-67)
  • ndc11
    7864178668
    946 mL in 1 BOTTLE, UNIT-DOSE (78641-786-68)

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": {
    "362a6b6d-862d-4322-87a8-5b3a07fbe174": {
      "match": "brand_token",
      "title": "EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]",
      "spl_version": "8",
      "published_date": "2025-11-25"
    }
  },
  "productid": "78641-786_c4f783d3-b047-ab39-e053-2995a90ab6f3",
  "productndc": "78641-786",
  "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": "Eyewash",
  "active_ingred_unit": "mL/473mL",
  "application_number": "NDA022305",
  "marketing_category": "NDA",
  "nonproprietary_name": "Eyewash",
  "start_marketing_date": "20210617",
  "active_numerator_strength": "465"
}

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