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

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 Lubricant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBOXYMETHYLCELLULOSE SODIUM	2.5 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
1547948	Internal RxNorm lookup
2106821	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
661d8764-8ae6-4229-9485-867553ee8e16	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
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
58790-001-15	TheraTears MD 58790-001
58790-001-15	TheraTears MD 58790-001
58790-001-30	TheraTears MD 58790-001
58790-001-30	TheraTears MD 58790-001
58790-001-31	TheraTears MD 58790-001
58790-001-31	TheraTears MD 58790-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58790-001-15	TheraTears Lubricant	1 in 1 CARTON	SOLUTION/ DROPS	1	10
58790-001-15	TheraTears Lubricant	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	10
58790-001-30	TheraTears Lubricant	1 in 1 CARTON	SOLUTION/ DROPS	1	10
58790-001-30	TheraTears Lubricant	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30	10
58790-001-31	TheraTears Lubricant	2 in 1 CARTON	SOLUTION/ DROPS	2	10
58790-001-31	TheraTears Lubricant	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58790-001-15	ML - Milliliter	58790-001	5ad2d490-d5b3-4932-89c1-d079a85b3d4a	1	2013-02-13
58790-001-30	ML - Milliliter	58790-001	bd0834d2-4f20-4d84-8613-964a66330a7d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
carboxymethylcellulose sodium	ACTIVE INGREDIENT	K679OBS311	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
carboxymethylcellulose	ACTIVE MOIETY	05JZI7B19X	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
calcium chloride	INACTIVE INGREDIENT	M4I0D6VV5M	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
diethylenetriamine pentamethylene phosphonic acid	INACTIVE INGREDIENT	0Q75589TM3	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
magnesium chloride	INACTIVE INGREDIENT	02F3473H9O	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
potassium chloride	INACTIVE INGREDIENT	660YQ98I10	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
sodium perborate	INACTIVE INGREDIENT	Y52BK1W96C	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
sodium phosphate	INACTIVE INGREDIENT	SE337SVY37	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2
water	INACTIVE INGREDIENT	059QF0KO0R	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58790-001	THERATEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MEDTECH PRODUCTS INC]	9	Current NDC, Legacy NDC, 6 package rows	20240704_661d8764-8ae6-4229-9485-867553ee8e16.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 24 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Systane Lubricant	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	15bc06ec-f3dc-3180-ca1a-106769a770ea	2023-12-15	Warnings	Exact identifier application number: M018
Systane ULTRA	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	2023-12-15	Warnings	Exact identifier application number: M018
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	7eaa93ca-c843-4c89-921b-c76659410dce	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	e48d82f0-2f18-e514-4caa-e397d6713b99	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Severe	HYPROMELLOSE	Alcon Laboratories, Inc.	a57854fc-f3a2-4fbb-b718-cd06f87a721e	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	538c2a89-efb5-4132-b678-5a78f23cb713	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Gel Drops	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	84388a75-9d11-48ce-bf5a-88f0580d2d03	2023-12-14	Warnings	Exact identifier application number: M018
Alcon Tears Lubricant Eye Drops	HYPROMELLOSE 2910	Alcon Laboratories, Inc.	89302e2b-882b-48d5-8df7-be37859b48ba	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Moderate Preservative Free	DEXTRAN 70, HYPROMELLOSE 2910	Alcon Laboratories, Inc.	37686e54-e64d-47c8-b082-b944a23cf6f1	2023-12-14	Warnings	Exact identifier application number: M018
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Exact identifier application number: M018
Altalube	MINERAL OIL AND PETROLATUM	Altaire Pharmaceuticals Inc.	eb65004c-c3a7-4079-bd75-f2857d30c68a	2023-12-09	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	Warnings	Exact identifier application number: M018
Rugby Lubricating Drops	POLYVINYL ALCOHOL	A-S Medication Solutions	f2e26f85-4081-425b-9c81-ac2a079a5743	2023-11-10	Warnings	Exact identifier application number: M018
Saline	NASAL	GERI-CARE PHARMACEUTICAL CORP	d293cc13-4043-0d58-e053-2995a90a3fbc	2023-10-24	Warnings	Exact identifier application number: M018
Eyeganics Organic Tears	GLYCERIN	Eyeganics LLC	42470af7-a3ae-4e14-88e0-04cd92db4b37	2023-10-13	Warnings	Exact identifier application number: M018
Refresh Digital PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	97e83e68-6374-4df4-93f6-d707fc32748d	2022-11-28	Warnings	Exact identifier application number: M018
Refresh Digital	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81	2022-11-28	Warnings	Exact identifier application number: M018
REFRESH OPTIVE	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	7f8d88af-fd3b-4138-af61-f24c59ccebd7	2022-09-23	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1547948	carboxymethylcellulose sodium 0.25 % Ophthalmic Solution	PSN	661d8764-8ae6-4229-9485-867553ee8e16	10
2106821	TheraTears 0.25 % Ophthalmic Solution	PSN	661d8764-8ae6-4229-9485-867553ee8e16	10
2106821	carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears]	SBD	661d8764-8ae6-4229-9485-867553ee8e16	10
1547948	carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution	SCD	661d8764-8ae6-4229-9485-867553ee8e16	10
1547948	carboxymethylcellulose sodium 0.25 % Ophthalmic Solution	SY	661d8764-8ae6-4229-9485-867553ee8e16	10
2106821	TheraTears 0.25 % Ophthalmic Solution	SY	661d8764-8ae6-4229-9485-867553ee8e16	10
2106821	TheraTears 2.5 MG/ML Ophthalmic Solution	SY	661d8764-8ae6-4229-9485-867553ee8e16	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58790-001-15	58790000115	1 BOTTLE, DROPPER in 1 CARTON (58790-001-15) / 15 mL in 1 BOTTLE, DROPPER	1999-07-01	0000-00-00	No	No	Current
58790-001-30	58790000130	1 BOTTLE, DROPPER in 1 CARTON (58790-001-30) / 30 mL in 1 BOTTLE, DROPPER	1999-07-01	0000-00-00	No	No	Current
58790-001-31	58790000131	2 BOTTLE, DROPPER in 1 CARTON (58790-001-31) / 30 mL in 1 BOTTLE, DROPPER	2020-12-01	0000-00-00	No	No	Current