Home NDC 57619-303 Splash Tears
Product NDC 57619-303
11-digit product format 576190303
Labeler code 57619
Product ID 57619-303_524658a5-3e39-2e46-e063-6294a90a48e3
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 2020-05-13
Substance HYPROMELLOSE 2910 (4000 MPA.S)
Active strength .2 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Tears
Listing expiration 2027-12-31 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 57619-303-01 Splash Tears 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 9 57619-303-01 Splash Tears 1 in 1 CARTON SOLUTION/ DROPS 1 9 57619-303-03 Splash Tears 1 in 1 CARTON SOLUTION/ DROPS 1 9 57619-303-03 Splash Tears 2 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57619-303 SPLASH TEARS (HYPROMELLOSE) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 9 Current NDC, Legacy NDC, 4 package rows 20250521_a58a8478-9cc5-aa39-e053-2995a90a347d.zip
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 Marketing end Sample Exclude flag Status 57619-303-01 57619030301 1 BOTTLE, DROPPER in 1 CARTON (57619-303-01) / 15 mL in 1 BOTTLE, DROPPER 2020-05-13 0000-00-00 No No Current 57619-303-03 57619030303 1 BOTTLE, DROPPER in 1 CARTON (57619-303-03) / 2 mL in 1 BOTTLE, DROPPER 2020-07-24 0000-00-00 Yes No Current