Refresh Optive

Product NDC
0023-3416
11-digit product format
000233416
Labeler code
0023
Product ID
0023-3416_873eb774-dc45-4f0a-9334-a5d8476d6264
Type
HUMAN OTC DRUG
Nonproprietary name
Carboxymethylcellulose Sodium, Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-08-22
Substance
CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN
Active strength
5; 9 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Refresh Optive
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM5 mg/mL
GLYCERIN9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK679OBS311, PDC6A3C0OX
Rxcui1100650

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
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
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
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
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
0023-3416-05Refresh Optive5 in 1 CARTONSOLUTION/ DROPS510
0023-3416-05Refresh Optive0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.410
0023-3416-30Refresh Optive0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.410
0023-3416-30Refresh Optive30 in 1 CARTONSOLUTION/ DROPS3010
0023-3416-60Refresh Optive0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.410
0023-3416-60Refresh Optive60 in 1 CARTONSOLUTION/ DROPS6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3416-30EA - Each0023-3416ca072ca6-67cf-44a4-b188-11050f04b3cd12012-07-24
0023-3416-60EA - Each0023-3416c282ce4e-bb1b-4fc0-b24d-c564bbb7e83012013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Carboxymethylcellulose SodiumACTIVE INGREDIENTK679OBS311REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
GlycerinACTIVE INGREDIENTPDC6A3C0OXREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
CarboxymethylcelluloseACTIVE MOIETY05JZI7B19XREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
GlycerinACTIVE MOIETYPDC6A3C0OXREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
Boric AcidINACTIVE INGREDIENTR57ZHV85D4REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
ErythritolINACTIVE INGREDIENTRA96B954X6REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
LevocarnitineINACTIVE INGREDIENT0G389FZZ9MREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
Magnesium ChlorideINACTIVE INGREDIENT02F3473H9OREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
potassium chlorideINACTIVE INGREDIENT660YQ98I10REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
sodium borateINACTIVE INGREDIENT91MBZ8H3QOREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RREFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3416REFRESH OPTIVE (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]8Current NDC, Legacy NDC, 6 package rows20231219_37e99aa8-02d6-4efb-a862-90bc7fcd5ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100650carboxymethylcellulose sodium 0.5 % / glycerin 0.9 % Ophthalmic SolutionPSN37e99aa8-02d6-4efb-a862-90bc7fcd5ca510
1100650carboxymethylcellulose sodium 5 MG/ML / glycerin 9 MG/ML Ophthalmic SolutionSCD37e99aa8-02d6-4efb-a862-90bc7fcd5ca510
1100650carboxymethylcellulose sodium 0.5 % / glycerin 0.9 % Ophthalmic SolutionSY37e99aa8-02d6-4efb-a862-90bc7fcd5ca510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-3416-05000233416055 VIAL, SINGLE-USE in 1 CARTON (0023-3416-05) / .4 mL in 1 VIAL, SINGLE-USE2008-08-220000-00-00YesNoCurrent
0023-3416-300002334163030 VIAL, SINGLE-USE in 1 CARTON (0023-3416-30) / .4 mL in 1 VIAL, SINGLE-USE2008-08-220000-00-00NoNoCurrent
0023-3416-600002334166060 VIAL, SINGLE-USE in 1 CARTON (0023-3416-60) / .4 mL in 1 VIAL, SINGLE-USE2008-08-220000-00-00NoNoCurrent