FDA.reportPublic FDA data

REFRESH TEARS

Product NDC
0023-0798
Requested package NDC
0023-0798-01
11-digit product format
000230798
Labeler code
0023
Product ID
0023-0798_104a1738-87e4-4eae-b584-93ceb264f77a
Type
HUMAN OTC DRUG
Nonproprietary name
carboxymethylcellulose sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-05-16
Substance
CARBOXYMETHYLCELLULOSE SODIUM
Active strength
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
REFRESH TEARS
Listing expiration
2026-12-31

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
329d1fe0-4432-4565-b7b1-65666bd86526Available 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
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
0023-0798-01REFRESH TEARS2 in 1 CARTONSOLUTION/ DROPS29
0023-0798-01REFRESH TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS159
0023-0798-02REFRESH TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS159
0023-0798-02REFRESH TEARS4 in 1 CARTONSOLUTION/ DROPS49
0023-0798-03REFRESH TEARS1 in 1 CARTONSOLUTION/ DROPS19
0023-0798-03REFRESH TEARS3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39
0023-0798-04REFRESH TEARS1 in 1 CARTONSOLUTION/ DROPS19
0023-0798-04REFRESH TEARS3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39
0023-0798-15REFRESH TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS159
0023-0798-15REFRESH TEARS1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0798-01ML - Milliliter0023-079862c6f21f-4516-4eea-ba68-d29b027aea0412012-07-24
0023-0798-02ML - Milliliter0023-079822f1d5bd-fff4-45c7-a80b-b75da37562a112012-07-24
0023-0798-15ML - Milliliter0023-0798a409ce19-82da-4f27-91e4-8c86819535dc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBOXYMETHYLCELLULOSE SODIUMACTIVE INGREDIENTK679OBS311REFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
CARBOXYMETHYLCELLULOSEACTIVE MOIETY05JZI7B19XREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4REFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10REFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
SODIUM CHLORITEINACTIVE INGREDIENTG538EBV4VFREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RREFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]10
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
boric acidINACTIVE INGREDIENTR57ZHV85D4REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
boric acidINACTIVE INGREDIENTR57ZHV85D4REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
chlorine dioxideINACTIVE INGREDIENT8061YMS4RMREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
chlorine dioxideINACTIVE INGREDIENT8061YMS4RMREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
magnesium chlorideINACTIVE INGREDIENT02F3473H9OREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
magnesium chlorideINACTIVE INGREDIENT02F3473H9OREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
sodium borateINACTIVE INGREDIENT91MBZ8H3QOREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
sodium borateINACTIVE INGREDIENT91MBZ8H3QOREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chlorateINACTIVE INGREDIENTT95DR77GMRREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
sodium chlorateINACTIVE INGREDIENTT95DR77GMRREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chloriteINACTIVE INGREDIENTG538EBV4VFREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium chloriteINACTIVE INGREDIENTG538EBV4VFREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MECHANICAL SERVANTS, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RREFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0798REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS REFRESH TEARS (CARBOXYMETHYLCELLULOSE SODIUM) KIT [ALLERGAN, INC.]9Current NDC, Legacy NDC, 10 package rows20240927_329d1fe0-4432-4565-b7b1-65666bd86526.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 25 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
ndc (package): 0023-0798-01
ndc (product): 0023-0798
ndc11 (package): 00023079801
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN3b94f67c-d675-4e16-846a-3ca39b0405e014
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD3b94f67c-d675-4e16-846a-3ca39b0405e014
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY3b94f67c-d675-4e16-846a-3ca39b0405e014
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY3b94f67c-d675-4e16-846a-3ca39b0405e014
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN329d1fe0-4432-4565-b7b1-65666bd865269
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD329d1fe0-4432-4565-b7b1-65666bd865269
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY329d1fe0-4432-4565-b7b1-65666bd865269
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY329d1fe0-4432-4565-b7b1-65666bd865269
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSNcd467181-9d56-4b11-9826-15b5357d06892
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCDcd467181-9d56-4b11-9826-15b5357d06892
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSYcd467181-9d56-4b11-9826-15b5357d06892
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSYcd467181-9d56-4b11-9826-15b5357d06892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-0798-01000230798012 BOTTLE, DROPPER in 1 CARTON (0023-0798-01) / 15 mL in 1 BOTTLE, DROPPER1997-05-160000-00-00NoNoCurrent