Home NDC 57619-305 Splash Refresh
Product NDC 57619-305
11-digit product format 576190305
Labeler code 57619
Product ID 57619-305_3dd7b774-826e-4155-e063-6394a90ad5bd
Type HUMAN OTC DRUG
Nonproprietary name Hypromellose
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler LABORATORIOS SOPHIA, S.A. DE C.V.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-08
Substance HYPROMELLOSE 2910 (4000 MPA.S)
Active strength .2 g/100mL
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 Refresh
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYPROMELLOSE 2910 (4000 MPA.S) .2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RN3152OP35 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359634 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57619-305-01 Splash Refresh 1 in 1 CARTON SOLUTION/ DROPS 1 11 57619-305-01 Splash Refresh 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 11
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 Marketing start Sample Exclude flag Status 57619-305-01 57619030501 1 BOTTLE, DROPPER in 1 CARTON (57619-305-01) / 15 mL in 1 BOTTLE, DROPPER 2025-08-08 No No Current