FDA.reportPublic FDA data

REFRESH CELLUVISC

Product NDC
0023-4554
11-digit product format
000234554
Labeler code
0023
Product ID
0023-4554_d557bb82-b2a0-4be8-80a2-196c328bff3f
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-10-04
Substance
CARBOXYMETHYLCELLULOSE SODIUM
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
REFRESH CELLUVISC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM10 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
579907Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b32ed9e8-d091-4f16-b416-5a62cdfee49aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-4554-05REFRESH CELLUVISC0.4 mL in 1 VIAL, SINGLE-USEGEL0.49
0023-4554-05REFRESH CELLUVISC5 in 1 CARTONGEL59
0023-4554-30REFRESH CELLUVISC30 in 1 CARTONGEL309
0023-4554-30REFRESH CELLUVISC0.4 mL in 1 VIAL, SINGLE-USEGEL0.49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-4554-30EA - Each0023-45540649df12-88d2-4290-a201-b12da7c5ec9512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MREFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4
potassium chlorideINACTIVE INGREDIENT660YQ98I10REFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4
sodium lactateINACTIVE INGREDIENTTU7HW0W0QTREFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RREFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-4554REFRESH CELLUVISC (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ALLERGAN, INC.]9Current NDC, Legacy NDC, 4 package rows20240202_b32ed9e8-d091-4f16-b416-5a62cdfee49a.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 12 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
application number: M018
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
application number: M018
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
application number: M018
Preferred Plus Pharmacy Redness Relief Eye DropsTETRAHYDROZOLINE HCLKinray9ffd67c4-b5c1-d587-e053-2a95a90ae3d02025-12-30WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops Soothing ReliefCARBOXYMETHYLCELLULOSE SODIUMLEADER/Cardinal Health 110, Inc.218629d4-2704-a503-e063-6294a90a39532025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMStrategic Sourcing Services LLCfb85ebc0-1570-972b-e053-6294a90a3dc42025-12-30WarningsExact identifier
application number: M018
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
application number: M018
Equate Optimal Hydration Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart, Inc.151b9723-5d5e-ac2b-e063-6294a90af0732025-12-30WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMWalmart Inc.152171db-2f2a-9d36-e063-6394a90a72252025-12-30WarningsExact identifier
application number: M018
Equate Moisturizing Comfort Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart Inc.152028bd-0429-720a-e063-6294a90a14652025-12-30WarningsExact identifier
application number: M018
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
application number: M018
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
application number: M018
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim46854996-a0b9-46b4-e063-6294a90aa4332025-12-22WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. LTD468559a0-9586-9982-e063-6394a90af4662025-12-22WarningsExact identifier
application number: M018
Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc4682f68d-6bdd-d860-e063-6394a90a2b522025-12-21WarningsExact identifier
application number: M018
Original Redness RelieverTETRAHYDROLIZINE HCLKC Pharmaceuticals4683b850-b0fc-5093-e063-6294a90aef442025-12-21WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMWalmart4449a55b-2cd4-0cb9-e063-6294a90aafbc2025-12-20WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart44494842-e38d-617c-e063-6294a90afaf82025-12-20WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579907carboxymethylcellulose sodium 1 % Ophthalmic GelPSNb32ed9e8-d091-4f16-b416-5a62cdfee49a9
579907carboxymethylcellulose sodium 0.01 MG/MG Ophthalmic GelSCDb32ed9e8-d091-4f16-b416-5a62cdfee49a9
579907carboxymethylcellulose sodium 1 % Ophthalmic GelSYb32ed9e8-d091-4f16-b416-5a62cdfee49a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-4554-05000234554055 VIAL, SINGLE-USE in 1 CARTON (0023-4554-05) / .4 mL in 1 VIAL, SINGLE-USE1989-10-040000-00-00YesNoCurrent
0023-4554-300002345543030 VIAL, SINGLE-USE in 1 CARTON (0023-4554-30) / .4 mL in 1 VIAL, SINGLE-USE1989-10-040000-00-00NoNoCurrent