FDA.reportPublic FDA data

BION TEARS

Product NDC
0065-9305
Requested package NDC
0065-9305-01
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
IngredientStrength
DEXTRAN 701 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
IdentifierFDA.report destination
7SA290YK68Internal UNII lookup
RN3152OP35Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309714Internal RxNorm lookup
1088217Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
538c2a89-efb5-4132-b678-5a78f23cb713Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-9305-01BION TEARS28 in 1 CARTONSOLUTION/ DROPS283
0065-9305-01BION TEARS0.4 mL in 1 VIALSOLUTION/ DROPS0.43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-9305-01EA - Each0065-93053b147621-9bde-46b8-aa52-abf670aebd0512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-9305BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]3Current NDC, 2 package rows20231215_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 20 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exchange Select Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLArmy and Air Force Exchange Service318bc025-c936-a066-e063-6294a90a47122024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops OriginalTETRAHYDROZOLINE HCLThe Kroger Co.318c17a1-fe08-508b-e063-6394a90a2e082024-01-01WarningsExact identifier
application number: M018
HEB Original Eye DropsTETRAHYDROZOLINE HCLHEB Grocery Company, LP318cb457-bb2d-a1ee-e063-6294a90a80192024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Mart, Inc.318dc92a-0707-d6a4-e063-6294a90ab78a2024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
application number: M018
Harris Teeter Eye Drops OriginalTETRAHYDROZOLINE HCLHarris Teeter, LLC.P31a1b962-27ad-97b1-e063-6294a90a77f12024-01-01WarningsExact identifier
application number: M018
CVP Sterile Eye DropsTETRAHYDROZOLINE HCLSalado Sales, Inc.31a216f8-28e9-ec8f-e063-6394a90aec492024-01-01WarningsExact identifier
application number: M018
Equaline Sterile Eye DropsTETRAHYDROZOLINE HCLUnited Natural Foods, Inc.31a25efb-a627-1a13-e063-6394a90a2ca32024-01-01WarningsExact identifier
application number: M018
Best Choice Eye Drops OriginalTETRAHYDROZOLINE HCLValu Merchandisers Company31a2a42a-bcfe-4f22-e063-6294a90ac60e2024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops OriginalTETRAHYDROZOLINE HCLDiscount Drug Mart, Inc.31a2efb2-3924-6a12-e063-6394a90ab0e22024-01-01WarningsExact identifier
application number: M018
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
application number: M018
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.31a98e6c-42df-6b56-e063-6294a90a35642024-01-01WarningsExact identifier
application number: M018
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
application number: M018
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
application number: M018
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
application number: M018
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye Drops Preservative-FreeCARBOXYMETHYLCELLULOSE SODIUMWal-Mart Stores, Inc.9228a39b-38d2-1dfc-e053-2a95a90a3c902023-12-23WarningsExact identifier
application number: M018
Equate Restore Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart, Inc.9e665ca2-4fa6-fdb4-e053-2a95a90abcca2023-12-23WarningsExact identifier
application number: M018
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088217BION TEARS 0.1 % / 0.3 % Ophthalmic SolutionPSN538c2a89-efb5-4132-b678-5a78f23cb7133
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic SolutionPSN538c2a89-efb5-4132-b678-5a78f23cb7133
1088217dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic Solution [Bion Tears]SBD538c2a89-efb5-4132-b678-5a78f23cb7133
309714dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic SolutionSCD538c2a89-efb5-4132-b678-5a78f23cb7133
1088217Bion Tears (dextran 70 0.1 % / hypromellose 0.3 % ) Ophthalmic SolutionSY538c2a89-efb5-4132-b678-5a78f23cb7133
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic DropsSY538c2a89-efb5-4132-b678-5a78f23cb7133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0065-9305-010006593050128 VIAL in 1 CARTON (0065-9305-01) / .4 mL in 1 VIAL28 vial2023-04-01NoNoCurrent