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
Ingredient	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K679OBS311	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
17a01236-130f-495b-9f8d-92b6a23b2dc5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58790-003-30	TheraTears	5 in 1 POUCH	GEL	5		11
58790-003-30	TheraTears	6 in 1 CARTON	GEL	6		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58790-003-30	EA - Each	58790-003	728d47fb-79ea-403c-840b-2ffb93816929	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
carboxymethylcellulose sodium	ACTIVE INGREDIENT	K679OBS311	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
carboxymethylcellulose	ACTIVE MOIETY	05JZI7B19X	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
calcium chloride	INACTIVE INGREDIENT	M4I0D6VV5M	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
magnesium chloride	INACTIVE INGREDIENT	02F3473H9O	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
potassium chloride	INACTIVE INGREDIENT	660YQ98I10	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
sodium borate	INACTIVE INGREDIENT	91MBZ8H3QO	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
sodium phosphate	INACTIVE INGREDIENT	SE337SVY37	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1
water	INACTIVE INGREDIENT	059QF0KO0R	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58790-003	THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [MEDTECH PRODUCTS INC]	10	Current NDC, Legacy NDC, 2 package rows	20241212_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 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCI	Retail Business Services, LLC	9ab96aed-21d3-11b6-e053-2995a90a7225	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops 30 ct	CARBOXYMETHYLCELLULOSE SODUIM	CVS Pharmacy, Inc.	8dbca077-c989-767a-e053-2995a90a7cf5	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Original Formula Eye Drops	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	002da62b-aec6-8e2a-e063-6294a90a5efc	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Artificial Tears Eye Drops 15mL	POLYVINYL ALCOHOL, POVIDONE	Retail Business Services, LLC	92fded6b-91fd-d82e-e053-2a95a90ab523	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Long Lasting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	00546df0-17d8-0e3c-e063-6294a90ae7b2	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Meijer, Inc.	e7a5677a-ff33-c039-e053-2a95a90ae6c7	2025-12-30	Warnings	Exact identifier application number: M018
TopCare Health Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Topcare Associates LLC	e8e9dfe5-3540-a4df-e053-2a95a90aaf98	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Meijer Distribution, Inc.	b245f99f-785a-efdc-e053-2995a90a4911	2025-12-30	Warnings	Exact identifier application number: M018
Equate Original Eye Drops	TETRAHYDROZOLINE HCL	Walmart, Inc.	eb8e5beb-4454-58c2-e053-2a95a90a66e0	2025-12-30	Warnings	Exact identifier application number: M018
Avenova Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	NovaBay Pharmaceuticals, Inc.	cd17f037-5aa5-0ef8-e053-2a95a90a39cb	2025-12-30	Warnings	Exact identifier application number: M018
Equate Redness and Dry Eye Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Wal-Mart Stores, Inc.	ae228018-9238-2cbd-e053-2995a90a8d99	2025-12-30	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walmart, Inc.	deebaf7f-f20d-4d7f-e053-2a95a90a4b4f	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Artificial Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Chain Drug Marketing Association, Inc.	1f669655-4bc7-0175-e063-6294a90a305a	2025-12-30	Warnings	Exact identifier application number: M018
Equate Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Walmart, Inc.	ead9f271-0f15-1fff-e053-2a95a90a93ac	2025-12-30	Warnings	Exact identifier application number: M018
Equate Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATE	Walmart, Inc.	eb8ed76b-9cd7-3636-e053-2a95a90a9583	2025-12-30	Warnings	Exact identifier application number: M018
CorneaCare Recover Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CorneaCare Inc.	1fd3a5ed-8963-5c8e-e063-6394a90a6527	2025-12-30	Warnings	Exact identifier application number: M018
Eye Love Heyedrate Long Lasting Hydration	GLYCERIN, POVIDONE	Physician Recommended Neutraceuticals, L.P.	f321dea1-3251-eaa8-e053-2995a90aaf95	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Chain Drug Marketing Assoc., Inc.	0cd1b36a-a07a-a1db-e063-6294a90a5994	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Quality Choice	1f682079-6e91-e14b-e063-6394a90a3f12	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Moisturizing Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Chain Drug Marketing Association, Inc.	1fb81759-5931-59c8-e063-6294a90a2277	2025-12-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K679OBS311	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	9004-32-4	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
579907	carboxymethylcellulose sodium 1 % Ophthalmic Gel	PSN	17a01236-130f-495b-9f8d-92b6a23b2dc5	11
998666	TheraTears 1 % Ophthalmic Gel	PSN	17a01236-130f-495b-9f8d-92b6a23b2dc5	11
998666	carboxymethylcellulose sodium 0.01 MG/MG Ophthalmic Gel [TheraTears]	SBD	17a01236-130f-495b-9f8d-92b6a23b2dc5	11
579907	carboxymethylcellulose sodium 0.01 MG/MG Ophthalmic Gel	SCD	17a01236-130f-495b-9f8d-92b6a23b2dc5	11
579907	carboxymethylcellulose sodium 1 % Ophthalmic Gel	SY	17a01236-130f-495b-9f8d-92b6a23b2dc5	11
998666	Thera Tears 1 % Ophthalmic Gel	SY	17a01236-130f-495b-9f8d-92b6a23b2dc5	11
998666	TheraTears 0.01 MG/MG Ophthalmic Gel	SY	17a01236-130f-495b-9f8d-92b6a23b2dc5	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58790-003-30	58790000330	6 POUCH in 1 CARTON (58790-003-30) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL	6 pouch	2018-12-07	0000-00-00	No	No	Current