Home NDC 69618-077 Sodium Chloride Hypertonicity Ophthalmic Solution, 5%
Product NDC 69618-077
11-digit product format 696180077
Labeler code 69618
Product ID 69618-077_2bc84e6b-f871-1be7-e063-6294a90ac878
Type HUMAN OTC DRUG
Nonproprietary name Sodium Chloride Hypertonicity Ophthalmic Solution, 5%
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Reliable 1 Laboritories LLC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-27
Substance SODIUM CHLORIDE
Active strength 50 mg/mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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 Sodium Chloride Hypertonicity Ophthalmic Solution, 5%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 451W47IQ8X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 730780 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 69618-077-55 Sodium Chloride Hypertonicity Ophthalmic Solution, 5% 1 in 1 CARTON SOLUTION/ DROPS 1 2 69618-077-55 Sodium Chloride Hypertonicity Ophthalmic Solution, 5% 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-077 SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% SOLUTION/ DROPS [RELIABLE 1 LABORITORIES LLC] 2 Current NDC, 2 package rows 20250213_29175c17-223e-5e92-e063-6294a90a71d2.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 · 499 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 69618-077-55 69618007755 1 BOTTLE, DROPPER in 1 CARTON (69618-077-55) / 15 mL in 1 BOTTLE, DROPPER 2024-12-27 No No Current