splash pure pf

Generic: propylene glycol

Labeler: laboratorios sophia, s.a. de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name splash pure pf
Generic Name propylene glycol
Labeler laboratorios sophia, s.a. de c.v.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

propylene glycol 6 mg/mL

Manufacturer
LABORATORIOS SOPHIA, S.A. DE C.V.

Identifiers & Regulatory

Product NDC 57619-307
Product ID 57619-307_4485d915-c0d9-6a42-e063-6294a90a66f1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2025-10-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57619307
Hyphenated Format 57619-307

Supplemental Identifiers

RxCUI
2265162
UNII
6DC9Q167V3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name splash pure pf (source: ndc)
Generic Name propylene glycol (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (57619-307-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (1)

propylene glycol (6 mg/mL)

Linked Drug Pages (1)

Splash Pure PF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4485d915-c0d9-6a42-e063-6294a90a66f1", "openfda": {"unii": ["6DC9Q167V3"], "rxcui": ["2265162"], "spl_set_id": ["40ad7ae5-1f2a-e3b1-e063-6294a90a6f84"], "manufacturer_name": ["LABORATORIOS SOPHIA, S.A. DE C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57619-307-01)  / 10 mL in 1 BOTTLE", "package_ndc": "57619-307-01", "marketing_start_date": "20251006"}], "brand_name": "Splash Pure PF", "product_id": "57619-307_4485d915-c0d9-6a42-e063-6294a90a66f1", "dosage_form": "EMULSION", "product_ndc": "57619-307", "generic_name": "propylene glycol", "labeler_name": "LABORATORIOS SOPHIA, S.A. DE C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Splash Pure PF", "active_ingredients": [{"name": "PROPYLENE GLYCOL", "strength": "6 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251006", "listing_expiration_date": "20261231"}