Home NDC 57619-307 Splash Pure PF
Product NDC 57619-307
11-digit product format 576190307
Labeler code 57619
Product ID 57619-307_4485d915-c0d9-6a42-e063-6294a90a66f1
Type HUMAN OTC DRUG
Nonproprietary name propylene glycol
Dosage form EMULSION
Route OPHTHALMIC
Labeler LABORATORIOS SOPHIA, S.A. DE C.V.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-06
Substance PROPYLENE GLYCOL
Active strength 6 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Splash Pure PF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPYLENE GLYCOL 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6DC9Q167V3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2265162 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57619-307-01 Splash Pure PF 10 mL in 1 BOTTLE EMULSION 10 4 57619-307-01 Splash Pure PF 1 in 1 CARTON EMULSION 1 4
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 57619-307-01 57619030701 1 BOTTLE in 1 CARTON (57619-307-01) / 10 mL in 1 BOTTLE 1 bottle 2025-10-06 No No Current