Home NDC 0065-8064 GenTeal Tears
Product NDC 0065-8064
11-digit product format 000658064
Labeler code 0065
Product ID 0065-8064_750c99c5-ade3-4759-870b-cb59248e9fa0
Type HUMAN OTC DRUG
Nonproprietary name Hypromellose
Dosage form GEL
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-31
Substance HYPROMELLOSE 2910 (4000 MPA.S)
Active strength .003 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 Tears
Brand name suffix Severe
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYPROMELLOSE 2910 (4000 MPA.S) .003 g/g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310932 Internal RxNorm lookup 793204 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 0065-8064-01 GenTeal Tears Severe 10 g in 1 TUBE GEL 10 4 0065-8064-01 GenTeal Tears Severe 1 in 1 CARTON GEL 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-8064 GENTEAL TEARS SEVERE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231215_a57854fc-f3a2-4fbb-b718-cd06f87a721e.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 0065-8064-01 00065806401 1 TUBE in 1 CARTON (0065-8064-01) / 10 g in 1 TUBE 1 tube 2019-12-31 0000-00-00 No No Current