Home NDC 0065-0419 BION TEARS
Product NDC 0065-0419
11-digit product format 000650419
Labeler code 0065
Product ID 0065-0419_34aa9128-4bc4-45a6-aeae-a8c1f7699183
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 1992-10-19
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 0065-0419-18 BION TEARS 28 in 1 CARTON SOLUTION/ DROPS 28 11 0065-0419-18 BION TEARS 0.4 mL in 1 VIAL SOLUTION/ DROPS 0.4 11 0065-0419-28 BION TEARS 0.4 mL in 1 VIAL SOLUTION/ DROPS 0.4 11 0065-0419-28 BION TEARS 28 in 1 CARTON SOLUTION/ DROPS 28 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dextran 70 ACTIVE INGREDIENT 7SA290YK68 BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Hypromellose 2910 (4000 Mpa.s) ACTIVE INGREDIENT RN3152OP35 BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Dextran 70 ACTIVE MOIETY 7SA290YK68 BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Hypromelloses ACTIVE MOIETY 3NXW29V3WO BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Calcium Chloride INACTIVE INGREDIENT M4I0D6VV5M BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Carbon Dioxide INACTIVE INGREDIENT 142M471B3J BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Magnesium Chloride INACTIVE INGREDIENT 02F3473H9O BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Potassium Chloride INACTIVE INGREDIENT 660YQ98I10 BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Sodium Bicarbonate INACTIVE INGREDIENT 8MDF5V39QO BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1 Zinc Chloride INACTIVE INGREDIENT 86Q357L16B BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0419 BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20231215_e48d82f0-2f18-e514-4caa-e397d6713b99.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 0065-0419-18 00065041918 28 VIAL in 1 CARTON (0065-0419-18) > .4 mL in 1 VIAL 28 vial 2000-10-20 0000-00-00 No No Current 0065-0419-28 00065041928 0.4 mL in 1 VIAL 0.4 ml Historical