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United States · US · US:0065-0454_c3c56913-9741-44fb-8f63-b355393be140

Systane

UNIISPL

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

Identification

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

Packs · 1

  • ndc11
    0065045407
    10 mL in 1 BOTTLE, DROPPER (0065-0454-07)

Annotations

UNII (FDA Substance ID)
B697894SGQ
POLYETHYLENE GLYCOL 400
RxCUI 8514
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "B697894SGQ",
    "rxcui": "8514",
    "inchikey": null,
    "display_name": "POLYETHYLENE GLYCOL 400",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1": {
      "match": "brand_token",
      "title": "SYSTANE PRO PF (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]",
      "spl_version": "4",
      "published_date": "2026-05-14"
    }
  },
  "productid": "0065-0454_c3c56913-9741-44fb-8f63-b355393be140",
  "productndc": "0065-0454",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
  "proprietary_name": "Systane",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "M018",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "polyethylene glycol 400 and propylene glycol",
  "start_marketing_date": "20110209",
  "active_numerator_strength": "4; 3"
}

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