FDA.reportPublic FDA data

carboxymethylcellulose sodium

Product NDC
50268-067
11-digit product format
502680067
Labeler code
50268
Product ID
50268-067_47e22d5a-9c73-0660-e063-6294a90aec62
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
AvPAK
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-19
Substance
CARBOXYMETHYLCELLULOSE SODIUM
Active strength
5 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
carboxymethylcellulose sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1188426Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b478a695-ded0-2e5f-e053-2995a90ac45eAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-067-302026-01-29C16284748780-149896155-ab18-586f-e063-e6dba90add90Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (preservative free) Lubricant Eye Drops
50268-067-502026-01-29C16284748780-149896155-ab18-586f-e063-e6dba90add90Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (preservative free) Lubricant Eye Drops
50268-067-702026-01-29C16284748780-149896155-ab18-586f-e063-e6dba90add90Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (preservative free) Lubricant Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-067-30carboxymethylcellulose sodium30 in 1 CARTONSOLUTION/ DROPS306
50268-067-30carboxymethylcellulose sodium0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.46
50268-067-50carboxymethylcellulose sodium0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.46
50268-067-50carboxymethylcellulose sodium50 in 1 CARTONSOLUTION/ DROPS506
50268-067-70carboxymethylcellulose sodium0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.46
50268-067-70carboxymethylcellulose sodium70 in 1 CARTONSOLUTION/ DROPS706

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-067-30EA - Each50268-0678d70d39e-1fe7-4f88-9f69-ed89d4e6167212022-02-07
50268-067-50EA - Each50268-0674128c31a-16f6-47bb-81b3-a510f96bc56512022-02-07
50268-067-70EA - Each50268-06751ae6cf6-69d1-4c57-b1e1-1642045ab6f512022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-067CARBOXYMETHYLCELLULOSE SODIUM SOLUTION/ DROPS [AVPAK]5Current NDC, Legacy NDC, 6 package rows20240308_b478a695-ded0-2e5f-e053-2995a90ac45e.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 9 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
application number: M018
DG Original Eye DropsTETRAHYDROZOLINE HCLDolgencorp LLC9cb2123c-3ed4-ce8f-e053-2995a90a0ab82025-12-30WarningsExact identifier
application number: M018
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
application number: M018
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
application number: M018
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
application number: M018
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
application number: M018
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
application number: M018
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
application number: M018
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
application number: M018
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
application number: M018
Publix Moisturizing Relief Eye DropsCARBOXYMETHYLCELLULOSE SODIUMPublix Super Markets, Inc.9b391400-c53b-7c7b-e053-2995a90a27312025-12-30WarningsExact identifier
application number: M018
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
application number: M018
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
application number: M018
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
application number: M018
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact identifier
application number: M018
Winco Original Formula Eye DropsTETRAHYDROZOLINE HCLWinCo Foods, LLC44266952-4054-4c12-b3fc-d0543fe54fe22025-12-30WarningsExact identifier
application number: M018
Winco Irritation Relief EyeTETRAHYDROZOLINE HCL, ZINC SULFATEWinCo Foods, LLC60565184-5745-43a5-92b2-ab45b27e8bc62025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSNb478a695-ded0-2e5f-e053-2995a90ac45e6
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCDb478a695-ded0-2e5f-e053-2995a90ac45e6
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSYb478a695-ded0-2e5f-e053-2995a90ac45e6
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSYb478a695-ded0-2e5f-e053-2995a90ac45e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50268-067-305026800673030 VIAL, SINGLE-USE in 1 CARTON (50268-067-30) / .4 mL in 1 VIAL, SINGLE-USE2020-11-190000-00-00NoNoCurrent
50268-067-505026800675050 VIAL, SINGLE-USE in 1 CARTON (50268-067-50) / .4 mL in 1 VIAL, SINGLE-USE2020-11-190000-00-00NoNoCurrent
50268-067-705026800677070 VIAL, SINGLE-USE in 1 CARTON (50268-067-70) / .4 mL in 1 VIAL, SINGLE-USE2020-11-190000-00-00NoNoCurrent