FDA.reportPublic FDA data

REFRESH TEARS

Product NDC
0023-0798
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

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 Identifiers#

Field, Values table
FieldValues
UniiK679OBS311
Rxcui1188426

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

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
0023-0798-02000230798024 BOTTLE, DROPPER in 1 CARTON (0023-0798-02) > 15 mL in 1 BOTTLE, DROPPER1997-05-160000-00-00NoNoCurrent
0023-0798-03000230798031 BOTTLE, DROPPER in 1 CARTON (0023-0798-03) / 3 mL in 1 BOTTLE, DROPPER1997-05-160000-00-00YesNoCurrent
0023-0798-04000230798041 BOTTLE, DROPPER in 1 CARTON (0023-0798-04) / 3 mL in 1 BOTTLE, DROPPER1997-05-160000-00-00YesNoCurrent
0023-0798-15000230798151 BOTTLE, DROPPER in 1 CARTON (0023-0798-15) / 15 mL in 1 BOTTLE, DROPPER1997-05-160000-00-00NoNoCurrent