Splash Pure PF

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLABORATORIOS SOPHIA, S.A. DE C.V.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5761930701
1 BOTTLE in 1 CARTON (57619-307-01) / 10 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

6DC9Q167V3

PROPYLENE GLYCOL

RxCUI 34693

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6DC9Q167V3",
    "rxcui": "34693",
    "inchikey": "DNIAPMSPPWPWGF-UHFFFAOYSA-N",
    "display_name": "PROPYLENE GLYCOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "a58a8478-9cc5-aa39-e053-2995a90a347d": {
      "match": "brand_token",
      "title": "SPLASH TEARS (HYPROMELLOSE) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "57619-307_4485d915-c0d9-6a42-e063-6294a90a66f1",
  "productndc": "57619-307",
  "dosage_form": "EMULSION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PROPYLENE GLYCOL",
  "proprietary_name": "Splash Pure PF",
  "active_ingred_unit": "mg/mL",
  "application_number": "M018",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "propylene glycol",
  "start_marketing_date": "20251006",
  "active_numerator_strength": "6"
}

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