Home NDC 43116-051 Eye CareSpray
Product NDC 43116-051
11-digit product format 431160051
Labeler code 43116
Product ID 43116-051_52aef21b-427c-29de-e063-6394a90aff02
Type HUMAN OTC DRUG
Nonproprietary name Eyelid Cleansing Spray
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Shenzhen Shierjie Biological Engineering Co., LTD
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-26
Substance MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL; 4-TERPINEOL
Active strength .001; .002 U/100mL; U/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 Eye CareSpray
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL .001 U/100mL 4-TERPINEOL .002 U/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VIF565UC2G Internal UNII lookup L65MV77ZG6 Internal UNII 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 43116-051-01 Eye CareSpray 50 mL in 1 BOTTLE SOLUTION 50 1 43116-051-02 Eye CareSpray 1 in 1 POUCH SOLUTION 1 1 43116-051-03 Eye CareSpray 2 in 1 CARTON SOLUTION 2 1
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 23 of 49 · 969 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43116-051-01 43116005101 50 mL in 1 BOTTLE 50 ml Historical 43116-051-02 43116005102 1 in 1 POUCH Historical 43116-051-03 43116005103 2 POUCH in 1 CARTON (43116-051-03) / 1 BOTTLE in 1 POUCH (43116-051-02) / 50 mL in 1 BOTTLE (43116-051-01) 2 pouch 2026-05-26 No No Current