FDA.reportPublic FDA data

FREDS ADVANCED EYE DROPS

Product NDC
55315-118
11-digit product format
553150118
Labeler code
55315
Product ID
55315-118_39f6f573-e51d-4669-8273-3ef195025762
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
FREDS, INC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-118-152020-01-31C16284748780-19d75b9cf-e348-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-118-15FREDS ADVANCED EYE DROPS15 mL in 1 BOTTLESOLUTION152
55315-118-15FREDS ADVANCED EYE DROPS1 in 1 CARTONSOLUTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 70ACTIVE INGREDIENT7SA290YK68FREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
POVIDONEACTIVE INGREDIENTFZ989GH94EFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
DEXTRAN 70ACTIVE MOIETY7SA290YK68FREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
POVIDONEACTIVE MOIETYFZ989GH94EFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077FREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4FREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RFREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-118FREDS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [FREDS, INC]2Legacy NDC, 2 package rows20121109_e34d24da-9f44-4bbb-9b1d-2aa175f578f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNe34d24da-9f44-4bbb-9b1d-2aa175f578f82
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDe34d24da-9f44-4bbb-9b1d-2aa175f578f82
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSYe34d24da-9f44-4bbb-9b1d-2aa175f578f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55315-118-155531501181515 mL in 1 BOTTLE15 mlHistorical