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 21 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Discount Drug Mart Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	31a98e6c-42df-6b56-e063-6294a90a3564	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Harris Teeter, LLC.	31ac6883-ffc6-39de-e063-6294a90a52dd	2024-01-01	Warnings	Exact identifier application number: M018
Exchange Select High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Army and Air Force Exchange Service	31ac8bd2-c2e9-6f2c-e063-6394a90adc72	2024-01-01	Warnings	Exact identifier application number: M018
CVS Health Fast Acting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS Pharmacy, Inc.	31addfd2-52f2-05b3-e063-6294a90a337f	2024-01-01	Warnings	Exact identifier application number: M018
Equate Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Wal-Mart Stores, Inc.	91fb8fb5-b871-4535-e053-2995a90a9b16	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops Preservative-Free	CARBOXYMETHYLCELLULOSE SODIUM	Wal-Mart Stores, Inc.	9228a39b-38d2-1dfc-e053-2a95a90a3c90	2023-12-23	Warnings	Exact identifier application number: M018
Equate Restore Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Walmart, Inc.	9e665ca2-4fa6-fdb4-e053-2a95a90abcca	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Advanced Moisturizer/Lubricant	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE	Strategic Sourcing Services LLC	0daa4e39-0447-44b6-a7d7-370b12bf9451	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	91f85a72-5270-e4db-e053-2995a90aeb21	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	e32233ef-ea15-45b8-8e83-b658cf4c56a0	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricant Eye Drops	POLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	b117ff0a-1a48-4022-96e6-52bc45f056fc	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	043ccc34-44ee-416a-88bc-f247774e9075	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricating Tears	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	58f0b6d7-6072-40fd-ba72-b3ed68834791	2023-12-23	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Cardinal Health	8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa	2023-12-23	Warnings	Exact identifier application number: M018
Leader Eye Wash	PURIFIED WATER	Cardinal Health	8d3ad11f-1945-f838-e053-2995a90a7aa5	2023-12-23	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Amerisource Bergen Drug Corp.	fd2dc23f-6ccc-2644-e053-6294a90a889e	2023-12-23	Warnings	Exact identifier application number: M018
Rite Aid Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Rite Aid Corporation	fa1b5b66-9643-e9a7-e053-6394a90ae3cf	2023-12-23	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops Long Lasting	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands, LLC	05a63929-fccd-2936-e063-6294a90aeac5	2023-12-23	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	9feadde4-fbe5-0c9e-e053-2995a90a9b30	2023-12-22	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