FDA.reportPublic FDA data

TheraTears

Product NDC
58790-003
11-digit product format
587900003
Labeler code
58790
Product ID
58790-003_5b0f0fc3-3f46-4acb-e063-6294a90a72af
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium
Dosage form
GEL
Route
OPHTHALMIC
Labeler
MEDTECH PRODUCTS INC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-07
Substance
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
TheraTears
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K679OBS311Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
579907Internal RxNorm lookup
998666Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
17a01236-130f-495b-9f8d-92b6a23b2dc5Available on FDA.report

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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
58790-003-30TheraTears5 in 1 POUCHGEL511
58790-003-30TheraTears6 in 1 CARTONGEL611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-003-30EA - Each58790-003728d47fb-79ea-403c-840b-2ffb9381692912020-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58790-003THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [MEDTECH PRODUCTS INC]10Current NDC, Legacy NDC, 2 package rows20241212_17a01236-130f-495b-9f8d-92b6a23b2dc5.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 13 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart443e214b-2680-79a9-e063-6294a90a68ba2025-12-20WarningsExact identifier
application number: M018
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
application number: M018
Original Redness RelieverTETRAHYDROLIZINE HCLWalmart4414f768-0c69-d041-e063-6294a90a5bd92025-12-20WarningsExact identifier
application number: M018
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
application number: M018
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
application number: M018
Signature Care Eye Drops Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEBetter Living Brands LLC901f3bbe-e1bb-4e44-879c-711e59813a7f2025-12-19WarningsExact identifier
application number: M018
STYE RELIEF SERUMCARBOXYMETHYLCELLULOSE SODIUM(CMC)Guangzhou Shimei Cosmetics Co., Ltd.45fa7962-b489-4613-e063-6394a90a59b02025-12-15WarningsExact identifier
application number: M018
Gentle Eyes Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTRP Company13f99af6-b7d8-a092-e063-6394a90a5daa2025-12-15WarningsExact identifier
application number: M018
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
application number: M018
Eyelash SerumEYELASH SERUMFlexiGo Inc4544adf7-bb24-cb10-e063-6294a90aa4142025-12-06WarningsExact identifier
application number: M018
Redness Reliever, Circle KTETRAHYDROZOLINE HYDROCHLORIDE LIQUIDLil' Drug Store products, Inc.44e95d70-f633-1e4e-e063-6294a90a9f212025-12-01WarningsExact identifier
application number: M018
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
application number: M018
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
application number: M018
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalgreen Companya39864a3-2407-7b7e-e053-2a95a90ab92f2025-11-19WarningsExact identifier
application number: M018
Walgreens Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalgreen Companya39919d5-84db-05df-e053-2995a90ab1d22025-11-19WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579907carboxymethylcellulose sodium 1 % Ophthalmic GelPSN17a01236-130f-495b-9f8d-92b6a23b2dc511
998666TheraTears 1 % Ophthalmic GelPSN17a01236-130f-495b-9f8d-92b6a23b2dc511
998666carboxymethylcellulose sodium 0.01 MG/MG Ophthalmic Gel [TheraTears]SBD17a01236-130f-495b-9f8d-92b6a23b2dc511
579907carboxymethylcellulose sodium 0.01 MG/MG Ophthalmic GelSCD17a01236-130f-495b-9f8d-92b6a23b2dc511
579907carboxymethylcellulose sodium 1 % Ophthalmic GelSY17a01236-130f-495b-9f8d-92b6a23b2dc511
998666Thera Tears 1 % Ophthalmic GelSY17a01236-130f-495b-9f8d-92b6a23b2dc511
998666TheraTears 0.01 MG/MG Ophthalmic GelSY17a01236-130f-495b-9f8d-92b6a23b2dc511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58790-003-30587900003306 POUCH in 1 CARTON (58790-003-30) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL6 pouch2018-12-070000-00-00NoNoCurrent