FDA.reportPublic FDA data

TheraTears

Product NDC
58790-002
Requested package NDC
58790-002-28
11-digit product format
587900002
Labeler code
58790
Product ID
58790-002_7fa25608-0b89-4e34-a2d8-1e64b46db208
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium
Dosage form
GEL
Route
OPHTHALMIC
Labeler
MEDTECH PRODUCTS INC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2002-12-01
Marketing end
0000-00-00
Substance
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58790-00258790-002-28DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
58790-002-28TheraTears7 in 1 CARTONGEL711
58790-002-28TheraTears0.6 mL in 1 POUCHGEL0.611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-002-28EA - Each58790-0024882d8d7-c2b4-413d-a4ef-50384ddb630b12013-02-13

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
58790-002THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [MEDTECH PRODUCTS INC]10Legacy 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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
ndc (package): 58790-002-28
ndc (product): 58790-002
ndc11 (package): 58790000228

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
58790-002-28587900002287 POUCH in 1 CARTON (58790-002-28) > .6 mL in 1 POUCH7 pouch2002-12-010000-00-00NoNoCurrent