FDA.reportPublic FDA data

TheraTears Lubricant

Product NDC
58790-000
11-digit product format
587900000
Labeler code
58790
Product ID
58790-000_5de4b737-f6bd-27d8-e063-6294a90a5f81
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MEDTECH PRODUCTS INC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-01
Substance
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Active strength
2.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58790-00058790-000-00DDiscontinued by firm2026-10-16
excluded packagepackage58790-00058790-000-20DDiscontinued by firm2026-10-16
excluded packagepackage58790-00058790-000-24DDiscontinued by firm2026-10-16
excluded packagepackage58790-00058790-000-32DDiscontinued by firm2026-10-16

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
TheraTears Lubricant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM2.5 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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
58790-000-00TheraTears Lubricant6 in 1 CARTONSOLUTION/ DROPS611
58790-000-00TheraTears Lubricant5 in 1 POUCHSOLUTION/ DROPS511
58790-000-20TheraTears Lubricant5 in 1 CARTONSOLUTION/ DROPS511
58790-000-20TheraTears Lubricant4 in 1 POUCHSOLUTION/ DROPS411
58790-000-24TheraTears Lubricant6 in 1 CARTONSOLUTION/ DROPS611
58790-000-24TheraTears Lubricant4 in 1 POUCHSOLUTION/ DROPS411
58790-000-30TheraTears Lubricant6 in 1 CARTONSOLUTION/ DROPS611
58790-000-30TheraTears Lubricant5 in 1 POUCHSOLUTION/ DROPS511
58790-000-32TheraTears Lubricant8 in 1 CARTONSOLUTION/ DROPS811
58790-000-32TheraTears Lubricant4 in 1 POUCHSOLUTION/ DROPS411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-000-30EA - Each58790-0007e5d4351-c5aa-44ab-a75d-23acb21914a012019-10-07
58790-000-32EA - Each58790-00005a92925-dc86-4bff-8432-79ef3b75117912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
boric acidINACTIVE INGREDIENTR57ZHV85D4THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
magnesium chlorideINACTIVE INGREDIENT02F3473H9OTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
potassium chlorideINACTIVE INGREDIENT660YQ98I10THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
sodium borateINACTIVE INGREDIENT91MBZ8H3QOTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
sodium phosphateINACTIVE INGREDIENTSE337SVY37THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1
waterINACTIVE INGREDIENT059QF0KO0RTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58790-000THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MEDTECH PRODUCTS INC]10Current NDC, Legacy NDC, 10 package rows20241215_797b0394-2f0f-4733-8d20-ec5bdf3e085d.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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vis Guard Lubricant Eye DropsPOLYVINYL ALCOHOL 1.4%Ulai Health LLCe9b0ed39-60c8-1093-e053-2a95a90a705b2026-01-13WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
application number: M018
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
application number: M018
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
application number: M018
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
application number: M018
AuroviscHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabe9100312-b105-50a6-e053-2a95a90ac31f2026-01-08WarningsExact identifier
application number: M018
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
application number: M018
VISTA Hypromellose Dry Eye ReliefHYPROMELLOSERed Wedding LLCb2c4954c-ed53-778a-e053-2a95a90ae0d02026-01-01WarningsExact identifier
application number: M018
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
application number: M018
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
application number: M018
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
application number: M018
Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMAmerisource Bergen Drug Corp.fd6b2be8-7e00-3765-e053-6294a90a40612025-12-30WarningsExact identifier
application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
application number: M018
Medi-First Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUnifirst First Aid Corporationa4e651cc-adf0-af9e-e053-2995a90ace5a2025-12-30WarningsExact identifier
application number: M018
Green Guard Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUniFirst First Aid Corporationc3f04fdb-9fc1-797d-e053-2995a90afe802025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionPSN797b0394-2f0f-4733-8d20-ec5bdf3e085d11
2106821TheraTears 0.25 % Ophthalmic SolutionPSN797b0394-2f0f-4733-8d20-ec5bdf3e085d11
2106821carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears]SBD797b0394-2f0f-4733-8d20-ec5bdf3e085d11
1547948carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic SolutionSCD797b0394-2f0f-4733-8d20-ec5bdf3e085d11
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionSY797b0394-2f0f-4733-8d20-ec5bdf3e085d11
2106821TheraTears 0.25 % Ophthalmic SolutionSY797b0394-2f0f-4733-8d20-ec5bdf3e085d11
2106821TheraTears 2.5 MG/ML Ophthalmic SolutionSY797b0394-2f0f-4733-8d20-ec5bdf3e085d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58790-000-00587900000006 POUCH in 1 CARTON (58790-000-00) > 5 VIAL in 1 POUCH > .6 mL in 1 VIAL6 pouch2018-12-070000-00-00NoNoCurrent
58790-000-20587900000205 POUCH in 1 CARTON (58790-000-20) > 4 APPLICATOR in 1 POUCH > 19.2 mL in 1 APPLICATOR5 pouch1995-01-010000-00-00NoNoCurrent
58790-000-24587900000246 POUCH in 1 CARTON (58790-000-24) > 4 APPLICATOR in 1 POUCH > 19.2 mL in 1 APPLICATOR6 pouch1995-01-010000-00-00NoNoCurrent
58790-000-30587900000306 POUCH in 1 CARTON (58790-000-30) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL6 pouch2018-12-070000-00-00NoNoCurrent
58790-000-32587900000328 POUCH in 1 CARTON (58790-000-32) > 4 APPLICATOR in 1 POUCH > 19.2 mL in 1 APPLICATOR8 pouch1995-01-010000-00-00NoNoCurrent