FDA.reportPublic FDA data

CVS Advanced Eye Drops

Product NDC
51316-129
11-digit product format
513160129
Labeler code
51316
Product ID
51316-129_47450633-bcd7-6f07-e063-6294a90a96b1
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CVS Pharmacy, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-19
Substance
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.1; 1; 1; .05 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CVS Advanced Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 70.1 g/100mL
POLYETHYLENE GLYCOL 4001 g/100mL
POVIDONE1 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SA290YK68, B697894SGQ, FZ989GH94E, 0YZT43HS7D
Rxcui996202

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-129-01CVS Advanced Eye Drops1 in 1 BOXSOLUTION/ DROPS13
51316-129-01CVS Advanced Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-129CVS ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CVS PHARMACY, INC.]2Current NDC, 2 package rows20231224_f74a2fca-902c-f68a-e053-6394a90abb88.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 SolutionPSNf74a2fca-902c-f68a-e053-6394a90abb883
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDf74a2fca-902c-f68a-e053-6394a90abb883
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSYf74a2fca-902c-f68a-e053-6394a90abb883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-129-01513160129011 BOTTLE, DROPPER in 1 BOX (51316-129-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-19NoNoHistorical