FDA.reportPublic FDA data

CVS Hydration Eye Drops

Manufacturer
CVS | KC Pharmaceuticals, Inc. | Unimed
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:47

Label at a glance#

ProductCVS Hydration Eye Drops
Active ingredientPROPYLENE GLYCOL, POLYETHYLENE GLYCOL 400
Label structure8 sections

Dosage and administration

put 1 or 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

OTC - PURPOSE SECTION

Lubricant

Lubricant

Use

INDICATIONS & USAGE SECTION

  • for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • do not touch the tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor

OTC - STOP USE SECTION

if you experience any of the following:

  • eye pain
  • changes in vision occur
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Keep out of reach of childeren.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

put 1 or 2 drops in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

Store at temperature, not exceeding 59°F (15°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium hydroxide

CVS Hydration Eye Drops

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Hydration Eye DropsCVS Hydration Eye Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN5
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD5
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428557938GTIN-13: 0050428557938
EAN-13: 0050428557938
GTIN-12: 050428557938
UPC-A: 050428557938
GTIN storage (14 digits): 00050428557938		CVS Hydration Eye Drops.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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
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
51316-615-10CVS Hydration Eye Drops1 in 1 BOXSOLUTION/ DROPS15
51316-615-10CVS Hydration Eye Drops10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-61551316-615-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
ndc (package): 51316-615-10
ndc (product): 51316-615
ndc11 (package): 51316061510
spl id: 474508e3-acb8-49b8-e063-6394a90aeeca
spl set id: ecab8fa3-6575-0dde-e053-2a95a90abd61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.