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 19 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
application number: M018
Capasil Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationb1a8e78c-57f0-1f3e-e053-2995a90acbd52024-10-01WarningsExact identifier
application number: M018
Mencylate Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationf824de86-9492-2e6b-e053-6294a90a6f2a2024-10-01WarningsExact identifier
application number: M018
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
application number: M018
PURPOSEOCTINOXATE, OCTISALATE AND OXYBENZONEBausch & Lomb Incorporateda1e14135-b8da-4cee-8c5b-1893572f4de42024-09-25WarningsExact identifier
application number: M018
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
application number: M018
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
application number: M018
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
application number: M018
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
application number: M018
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
application number: M018
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
application number: M018
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
application number: M018
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
application number: M018
Eyes Alive LubricatingCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDRIVIERA PHARMA INCb6966691-6884-438c-9f89-5924089226e12024-05-31WarningsExact identifier
application number: M018
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact 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