FDA.reportPublic FDA data

REFRESH PLUS

Product NDC
0023-0403
11-digit product format
000230403
Labeler code
0023
Product ID
0023-0403_8fc924b2-2bb1-46ac-845b-41ef1570380e
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
1996-10-09
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 PLUS
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
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
0023-0403-05REFRESH PLUS5 in 1 CARTONSOLUTION/ DROPS512
0023-0403-05REFRESH PLUS0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.412
0023-0403-10REFRESH PLUS100 in 1 CARTONSOLUTION/ DROPS10012
0023-0403-10REFRESH PLUS0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.412
0023-0403-30REFRESH PLUS30 in 1 CARTONSOLUTION/ DROPS3012
0023-0403-30REFRESH PLUS0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.412
0023-0403-50REFRESH PLUS50 in 1 CARTONSOLUTION/ DROPS5012
0023-0403-50REFRESH PLUS0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.412
0023-0403-70REFRESH PLUS0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.412
0023-0403-70REFRESH PLUS70 in 1 CARTONSOLUTION/ DROPS7012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0403-30EA - Each0023-04031b7dba73-1c21-4d6c-95c5-36b7766aa4cc12012-07-24
0023-0403-50EA - Each0023-040320a7b344-7c02-4d09-b58e-5008980f2d8212012-07-24
0023-0403-70EA - Each0023-040314e7ba33-8c0f-4406-a1fb-d69442f760da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS311REFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
carboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
hydrochloric acidINACTIVE INGREDIENTQTT17582CBREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
magnesium chlorideINACTIVE INGREDIENT02F3473H9OREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
potassium chlorideINACTIVE INGREDIENT660YQ98I10REFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
sodium lactateINACTIVE INGREDIENTTU7HW0W0QTREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5
waterINACTIVE INGREDIENT059QF0KO0RREFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0403REFRESH PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]12Current NDC, Legacy NDC, 10 package rows20241003_0f6a4b4b-cde6-4518-84b5-ce997f1154a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN0f6a4b4b-cde6-4518-84b5-ce997f1154a712
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD0f6a4b4b-cde6-4518-84b5-ce997f1154a712
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY0f6a4b4b-cde6-4518-84b5-ce997f1154a712
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY0f6a4b4b-cde6-4518-84b5-ce997f1154a712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-0403-05000230403055 VIAL, SINGLE-USE in 1 CARTON (0023-0403-05) / .4 mL in 1 VIAL, SINGLE-USE1996-10-090000-00-00YesNoCurrent
0023-0403-1000023040310100 VIAL, SINGLE-USE in 1 CARTON (0023-0403-10) / .4 mL in 1 VIAL, SINGLE-USE1996-10-090000-00-00NoNoCurrent
0023-0403-300002304033030 VIAL, SINGLE-USE in 1 CARTON (0023-0403-30) / .4 mL in 1 VIAL, SINGLE-USE1996-10-090000-00-00NoNoCurrent
0023-0403-500002304035050 VIAL, SINGLE-USE in 1 CARTON (0023-0403-50) / .4 mL in 1 VIAL, SINGLE-USE1996-10-090000-00-00NoNoCurrent
0023-0403-700002304037070 VIAL, SINGLE-USE in 1 CARTON (0023-0403-70) / .4 mL in 1 VIAL, SINGLE-USE1996-10-090000-00-00NoNoCurrent