FDA.reportPublic FDA data

Code Red Eye Drops Redness Relief

Manufacturer
4 Trees, LLC | KC Pharmaceuticals, Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:45

Label at a glance#

ProductCode Red Eye Drops Redness Relief
Active ingredientPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Purposes

OTC - PURPOSE SECTION

Lubricant

Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lenses before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for 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) up to 4 times daily

Other information

OTHER SAFETY INFORMATION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, dextran, edetate disodium, povidone, purified water, sodium borate, sodium chloride

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-729-5397

Code Red Eye Drops Redness Relief 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Code Red Eye Drops Redness Relief 15mLCode Red Eye Drops Redness Relief 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN2
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD2
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83817-963-01Code Red Eye Drops Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
83817-963-01Code Red Eye Drops Redness Relief1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83817-963CODE RED EYE DROPS REDNESS RELIEF (POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [4 TREES, LLC]2Current NDC, 2 package rows20250212_0aa08018-cc2d-d947-e063-6394a90a914a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83817-96383817-963-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POVIDONEFZ989GH94EIACT
DEXTRAN 707SA290YK68IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
SODIUM CHLORIDE451W47IQ8XIACT
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT

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
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
ndc (package): 83817-963-01
ndc (product): 83817-963
ndc11 (package): 83817096301
spl id: 2dc61a4e-5308-5145-e063-6294a90a06d7
spl set id: 0aa08018-cc2d-d947-e063-6394a90a914a

Reported adverse events (FAERS/openFDA)#

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