Home NDC 0065-0518 GenTeal
Product NDC 0065-0518
11-digit product format 000650518
Labeler code 0065
Product ID 0065-0518_d09a2d41-4976-47b8-827c-5082741f83b4
Type HUMAN OTC DRUG
Nonproprietary name mineral oil, white petrolatum
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-09-05
Substance MINERAL OIL; PETROLATUM
Active strength .03; .94 g/g; g/g
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 GenTeal
Brand name suffix Tears NIGHT-TIME
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL .03 g/g PETROLATUM .94 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 706820 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0065-0518-01 GenTeal Tears NIGHT-TIME 1 in 1 CARTON OINTMENT 1 6 0065-0518-01 GenTeal Tears NIGHT-TIME 3.5 g in 1 TUBE OINTMENT 3.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0518 GENTEAL TEARS NIGHT-TIME (MINERAL OIL, WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241208_9d5998a7-4f59-4293-87da-8419650a524d.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 Units Marketing start Marketing end Sample Exclude flag Status 0065-0518-01 00065051801 1 TUBE in 1 CARTON (0065-0518-01) / 3.5 g in 1 TUBE 1 tube 2019-09-05 0000-00-00 No No Current