Home NDC 0065-9305 BION TEARS
Product NDC 0065-9305
11-digit product format 000659305
Labeler code 0065
Product ID 0065-9305_99e11df4-015e-41eb-804d-85a3e0e6c5be
Type HUMAN OTC DRUG
Nonproprietary name Dextran, Hypromellose
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-01
Substance DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)
Active strength 1; 3 mg/mL; mg/mL
Pharmacologic classes Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [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 BION TEARS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTRAN 70 1 mg/mL HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SA290YK68 Internal UNII lookup 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 309714 Internal RxNorm lookup 1088217 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 0065-9305-01 BION TEARS 28 in 1 CARTON SOLUTION/ DROPS 28 3 0065-9305-01 BION TEARS 0.4 mL in 1 VIAL SOLUTION/ DROPS 0.4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-9305 BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 3 Current NDC, 2 package rows 20231215_538c2a89-efb5-4132-b678-5a78f23cb713.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 Sample Exclude flag Status 0065-9305-01 00065930501 28 VIAL in 1 CARTON (0065-9305-01) / .4 mL in 1 VIAL 28 vial 2023-04-01 No No Current