FDA.reportPublic FDA data

Refresh Digital

Product NDC
0023-6952
11-digit product format
000236952
Labeler code
0023
Product ID
0023-6952_3da0fde5-6ea9-4a90-9470-d3f6e19a0630
Type
HUMAN OTC DRUG
Nonproprietary name
Carboxymethylcellulose sodium, Glycerin, Polysorbate 80
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80
Active strength
5; 10; 5 mg/mL; 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 Digital
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM5 mg/mL
GLYCERIN10 mg/mL
POLYSORBATE 805 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK679OBS311, PDC6A3C0OX, 6OZP39ZG8H
Rxcui1241471

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-6952-02Refresh Digital2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS24
0023-6952-02Refresh Digital1 in 1 CARTONSOLUTION/ DROPS14
0023-6952-10Refresh Digital1 in 1 CARTONSOLUTION/ DROPS14
0023-6952-10Refresh Digital10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6952-10ML - Milliliter0023-6952a7d386ad-02ee-4119-b0d6-be2c40efa43312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-6952REFRESH DIGITAL (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]3Current NDC, Legacy NDC, 4 package rows20231214_b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionPSNb2bd34d4-fab9-4f4b-9be2-5d30b55f5b814
1241471carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic SolutionSCDb2bd34d4-fab9-4f4b-9be2-5d30b55f5b814
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionSYb2bd34d4-fab9-4f4b-9be2-5d30b55f5b814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-6952-02000236952021 BOTTLE, DROPPER in 1 CARTON (0023-6952-02) / 2 mL in 1 BOTTLE, DROPPER2020-08-010000-00-00YesNoCurrent
0023-6952-10000236952101 BOTTLE, DROPPER in 1 CARTON (0023-6952-10) / 10 mL in 1 BOTTLE, DROPPER2020-08-010000-00-00NoNoCurrent