FDA.reportPublic FDA data

TheraTears Lubricant

Product NDC
58790-001
11-digit product format
587900001
Labeler code
58790
Product ID
58790-001_f70d6b04-42bb-4b76-9c33-2303789f77c2
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
1999-07-01
Substance
CARBOXYMETHYLCELLULOSE SODIUM
Active strength
2.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TheraTears Lubricant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK679OBS311
Rxcui1547948, 2106821

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58790-001-152024-01-30C16284748780-11030e365-3183-111a-e063-dadaa90a10e2TheraTears MD 58790-001
58790-001-152024-01-30C16284748780-11030e365-3183-111a-e063-dadaa90a10e2TheraTears MD 58790-001
58790-001-302024-01-30C16284748780-11030e365-3183-111a-e063-dadaa90a10e2TheraTears MD 58790-001
58790-001-302024-01-30C16284748780-11030e365-3183-111a-e063-dadaa90a10e2TheraTears MD 58790-001
58790-001-312024-01-30C16284748780-11030e365-3183-111a-e063-dadaa90a10e2TheraTears MD 58790-001
58790-001-312024-01-30C16284748780-11030e365-3183-111a-e063-dadaa90a10e2TheraTears MD 58790-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58790-001-15TheraTears Lubricant1 in 1 CARTONSOLUTION/ DROPS110
58790-001-15TheraTears Lubricant15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1510
58790-001-30TheraTears Lubricant1 in 1 CARTONSOLUTION/ DROPS110
58790-001-30TheraTears Lubricant30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS3010
58790-001-31TheraTears Lubricant2 in 1 CARTONSOLUTION/ DROPS210
58790-001-31TheraTears Lubricant30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-001-15ML - Milliliter58790-0015ad2d490-d5b3-4932-89c1-d079a85b3d4a12013-02-13
58790-001-30ML - Milliliter58790-001bd0834d2-4f20-4d84-8613-964a66330a7d12013-02-13

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.)]2
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
boric acidINACTIVE INGREDIENTR57ZHV85D4THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
diethylenetriamine pentamethylene phosphonic acidINACTIVE INGREDIENT0Q75589TM3THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
magnesium chlorideINACTIVE INGREDIENT02F3473H9OTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
sodium perborateINACTIVE INGREDIENTY52BK1W96CTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
sodium phosphateINACTIVE INGREDIENTSE337SVY37THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2
waterINACTIVE INGREDIENT059QF0KO0RTHERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58790-001THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MEDTECH PRODUCTS INC]9Current NDC, Legacy NDC, 6 package rows20240704_661d8764-8ae6-4229-9485-867553ee8e16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionPSN661d8764-8ae6-4229-9485-867553ee8e1610
2106821TheraTears 0.25 % Ophthalmic SolutionPSN661d8764-8ae6-4229-9485-867553ee8e1610
2106821carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears]SBD661d8764-8ae6-4229-9485-867553ee8e1610
1547948carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic SolutionSCD661d8764-8ae6-4229-9485-867553ee8e1610
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionSY661d8764-8ae6-4229-9485-867553ee8e1610
2106821TheraTears 0.25 % Ophthalmic SolutionSY661d8764-8ae6-4229-9485-867553ee8e1610
2106821TheraTears 2.5 MG/ML Ophthalmic SolutionSY661d8764-8ae6-4229-9485-867553ee8e1610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58790-001-15587900001151 BOTTLE, DROPPER in 1 CARTON (58790-001-15) / 15 mL in 1 BOTTLE, DROPPER1999-07-010000-00-00NoNoCurrent
58790-001-30587900001301 BOTTLE, DROPPER in 1 CARTON (58790-001-30) / 30 mL in 1 BOTTLE, DROPPER1999-07-010000-00-00NoNoCurrent
58790-001-31587900001312 BOTTLE, DROPPER in 1 CARTON (58790-001-31) / 30 mL in 1 BOTTLE, DROPPER2020-12-010000-00-00NoNoCurrent