FDA.reportPublic FDA data

Code Red Eye Drops

Manufacturer
4 Trees LLC | Samson Pharmaceuticals Inc.
Effective date
2025-05-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:01:43

Label at a glance#

ProductCode Red Eye Drops Micro
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

relieves redness of the eye due to minor eye irritations temporary relief of burning and irritation due to dryness of the eyes protects against further irritation

Dosage and administration

Instill 1 to 2 drops in the affected eye(s) up to four times daily

Storage and handling

store at 15°–30°C (59°–86°F) keep tightly closed use before expiration date marked on the carton and bottle serious side effects associated with use of product may be reported to the phone number provided below

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Glycerin 0.25%Lubricant
Naphazoline HCL 0.012%Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • temporary relief of burning and irritation due to dryness of the eyes
  • protects against further irritation

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • narrow angle glaucoma
  • high blood pressure
  • diabetes
  • any eye injuries or infection

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • do not use if this solution changes color or becomes cloudy
  • pupils may become enlarged temporarily
  • remove contact lenses before using
  • replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Instill 1 to 2 drops in the affected eye(s) up to four times daily

Other information

STORAGE AND HANDLING SECTION

  • store at 15°–30°C (59°–86°F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle
  • serious side effects associated with use of product may be reported to the phone number provided below

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Borate

Questions?

OTC - QUESTIONS SECTION

1-888-995-9935

SPL UNCLASSIFIED SECTION

Manufactured by:
Samson®
Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW! Advanced Redness Formula

CODE RED®
MICRO

POCKET SIZE

Relieves
Redness
Fast!

Eye
Drops

✓ Moisturizes
✓ Soothes
✓ Relieves

Brings
Eyes Back
to Life

Made in the USA

STERILE | 0.27 FL OZ (8 mL)
NDC 83817-102-01

PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack
PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSN3
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCD3
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83817-102-01Code Red Eye DropsMicro1 in 1 BLISTER PACKSOLUTION/ DROPS13
83817-102-01Code Red Eye DropsMicro8 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS83

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83817-10283817-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
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 MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
ndc (package): 83817-102-01
ndc (product): 83817-102
ndc11 (package): 83817010201
spl id: 0c2fe7de-1fbb-401b-b3b4-5099a3cd7d24
spl set id: 2a15ea9a-ff67-446b-8b83-6517d25ff38a

Reported adverse events (FAERS/openFDA)#

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