FreshKote Lubricant Eye Drops

Product NDC
15821-101
11-digit product format
158210101
Labeler code
15821
Product ID
15821-101_798647b0-8e4c-39dc-e053-2991aa0a716d
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone/Polyvinyl Alcohol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
FOCUS Laboratories, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-04-01
Marketing end
0000-00-00
Substance
POVIDONE K29/32; POLYVINYL ALCOHOL
Active strength
20 g/1000mL; g/1000mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15821-101-152020-01-31C16284748780-19d75b9d1-1488-f424-e053-dadaa90a57ce6397ebc5-0670-4dc0-8660-6c0f733e6fd1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15821-101-15ML - Milliliter15821-101138ae3d7-fff1-4b2a-8817-92f89fc1d5ba12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J990FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
POVIDONE K29/32ACTIVE INGREDIENT390RMW2PEQFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
POLYVINYL ALCOHOLACTIVE MOIETY532B59J990FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
POVIDONE K29/32ACTIVE MOIETY390RMW2PEQFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
POLIXETONIUMINACTIVE INGREDIENTEJT309W86CFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RFRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15821-101FRESHKOTE LUBRICANT EYE DROPS (POVIDONE/POLYVINYL ALCOHOL) SOLUTION/ DROPS [FOCUS LABORATORIES, INC.]6Legacy NDC20181031_6397ebc5-0670-4dc0-8660-6c0f733e6fd1.zip