Home NDC 57619-304 Splash Redness Reliever
Product NDC 57619-304
11-digit product format 576190304
Labeler code 57619
Product ID 57619-304_351e11b7-7c46-9bc7-e063-6294a90a46a7
Type HUMAN OTC DRUG
Nonproprietary name Hypromellose, Naphazoline hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler LABORATORIOS SOPHIA, S.A. DE C.V.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-25
Substance HYPROMELLOSE 2910 (4000 MPA.S); NAPHAZOLINE HYDROCHLORIDE
Active strength .2; .02 g/100mL; 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 Redness Reliever
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYPROMELLOSE 2910 (4000 MPA.S) .2 g/100mL NAPHAZOLINE HYDROCHLORIDE .02 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RN3152OP35 Internal UNII lookup MZ1131787D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2636530 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 57619-304-01 Splash Redness Reliever 1 in 1 CARTON SOLUTION/ DROPS 1 4 57619-304-01 Splash Redness Reliever 15 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57619-304 SPLASH REDNESS RELIEVER (HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.] 4 Current NDC, 2 package rows 20250521_fa4140e6-dc80-da99-e053-6294a90a194f.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 Sample Exclude flag Status 57619-304-01 57619030401 1 BOTTLE, PLASTIC in 1 CARTON (57619-304-01) / 15 mL in 1 BOTTLE, PLASTIC 2023-04-25 No No Current