FDA.reportPublic FDA data

TheraTears Extra

Product NDC
58790-007
11-digit product format
587900007
Labeler code
58790
Product ID
58790-007_bf94724f-8ab9-45c2-855f-b7f37e3d6504
Type
HUMAN OTC DRUG
Nonproprietary name
Carboxymethylcellulose Sodium, Unspecified Form
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MEDTECH PRODUCTS INC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-16
Substance
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Active strength
2.5 mg/mL
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
TheraTears Extra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM2.5 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
1547948Internal RxNorm lookup
2106821Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77f504c1-b8e0-4371-ac3e-9d453d84714bAvailable 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
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
58790-007-15TheraTears Extra15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
58790-007-15TheraTears Extra1 in 1 CARTONSOLUTION/ DROPS15
58790-007-16TheraTears Extra2 in 1 CARTONSOLUTION/ DROPS25
58790-007-16TheraTears Extra15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-007-15ML - Milliliter58790-00770494c1a-8c2c-49a8-ba7c-aba12142e99c12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58790-007THERATEARS EXTRA (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM) SOLUTION/ DROPS [MEDTECH PRODUCTS INC]5Current NDC, Legacy NDC, 4 package rows20241212_77f504c1-b8e0-4371-ac3e-9d453d84714b.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 8 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EYE DROPSCARBOXYMETHYLCELLULOSE SODIUMFoshan Sugar Max Cosmetics CO.,Ltd26dbf100-593e-3778-e063-6394a90adf262025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Original FormulaTETRAHYDROZOLINE HCLGeiss, Destin & Dunn, Inc.9b44de58-6362-3811-e053-2995a90a2f372025-12-30WarningsExact identifier
application number: M018
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
application number: M018
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEGeiss, Destin & Dunn, Inc.9b24fbdd-780c-1ba2-e053-2a95a90ad60f2025-12-30WarningsExact identifier
application number: M018
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
application number: M018
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
application number: M018
Good Sense Lubricating Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMGoodSenseffd6428e-3bf5-8742-e053-6394a90a4c8f2025-12-30WarningsExact identifier
application number: M018
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
application number: M018
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Martf5f1d3da-5300-8211-e053-2a95a90a323a2025-12-30WarningsExact identifier
application number: M018
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
application number: M018
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
application number: M018
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
application number: M018
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
application number: M018
Family Wellness Original Redness Relief Eye DropsTETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabf540a-8d5c-bb1c-e053-6394a90a75c22025-12-30WarningsExact identifier
application number: M018
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionPSN77f504c1-b8e0-4371-ac3e-9d453d84714b5
2106821TheraTears 0.25 % Ophthalmic SolutionPSN77f504c1-b8e0-4371-ac3e-9d453d84714b5
2106821carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears]SBD77f504c1-b8e0-4371-ac3e-9d453d84714b5
1547948carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic SolutionSCD77f504c1-b8e0-4371-ac3e-9d453d84714b5
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionSY77f504c1-b8e0-4371-ac3e-9d453d84714b5
2106821TheraTears 0.25 % Ophthalmic SolutionSY77f504c1-b8e0-4371-ac3e-9d453d84714b5
2106821TheraTears 2.5 MG/ML Ophthalmic SolutionSY77f504c1-b8e0-4371-ac3e-9d453d84714b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58790-007-15587900007151 BOTTLE, DROPPER in 1 CARTON (58790-007-15) / 15 mL in 1 BOTTLE, DROPPER2018-04-160000-00-00NoNoCurrent
58790-007-16587900007162 BOTTLE, DROPPER in 1 CARTON (58790-007-16) / 15 mL in 1 BOTTLE, DROPPER2020-12-010000-00-00NoNoCurrent