FDA.reportPublic FDA data

Avenova Lubricant Eye Drops High Performance

Manufacturer
NovaBay Pharmaceuticals, Inc. | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:37

Label at a glance#

ProductAvenova Lubricant Eye Drops High Performance
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure9 sections

Dosage and administration

instill 1 to 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 the temporary relief of burning and irritation due to 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 tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

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

instill 1 to 2 drops in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-890-0329

Email: sales@avenova.com

Avenova Lubricant Eye Drops High Performance 15mL twin pk

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avenova Lubricant Eye Drops High Performance 15mL twin pkAvenova Lubricant Eye Drops High Performance 15mL twin pk

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN3
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD3
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130857005004119GTIN-13: 0857005004119
EAN-13: 0857005004119
GTIN-12: 857005004119
UPC-A: 857005004119
GTIN storage (14 digits): 00857005004119		KC DL - Avenova Lub Eye Drops High Performance.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81963-101-102023-12-23C16284748780-1f386c64a-20ff-0266-e053-dadaa90a7c1aAvenova Lubricant Eye Drops High Performance 15mL twin pk (PLD)
81963-101-102023-01-30C16284748780-1f386c64a-20ff-0266-e053-dadaa90a7c1aAvenova Lubricant Eye Drops High Performance 15mL twin pk (PLD)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81963-101-10Avenova Lubricant Eye Drops High Performance2 in 1 BOXSOLUTION/ DROPS23
81963-101-10Avenova Lubricant Eye Drops High Performance15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81963-10181963-101-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQACTIB
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POTASSIUM CHLORIDE660YQ98I10IACT

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
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
ndc (package): 81963-101-10
ndc (product): 81963-101
ndc11 (package): 81963010110
spl id: 474940b5-b173-6e9c-e063-6394a90a8b01
spl set id: cd17f037-5aa5-0ef8-e053-2a95a90a39cb

Reported adverse events (FAERS/openFDA)#

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