Sunmark Eye Drops Original Formula

Manufacturer: Strategic Sourcing Services LLC | KC Pharmaceuticals, Inc.
Effective date: 2023-12-23
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:06:23

Label at a glance#

ProductSunmark Eye Drops Original Formula

Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

relieves redness of the eye due to minor eye irritations

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCL 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Uses

INDICATIONS & USAGE SECTION

relieves redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR 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 lens 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 chlidren

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

Store at 15 -30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	5
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	5
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	5
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-037-29	Sunmark Eye Drops Original Formula	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15		5
49348-037-29	Sunmark Eye Drops Original Formula	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-037	SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [STRATEGIC SOURCING SERVICES LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240103_33efa7e9-4c3a-4d72-af31-c5e35095c2ff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-037-29	ML - Milliliter	49348-037	3df8703d-582b-4e59-8d43-4c1617217a95	1	2014-10-03

Products#

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

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

Sunmark Eye Drops Original Formula
Tetrahydrozoline HCl
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
WATER
SODIUM BORATE
SODIUM CHLORIDE
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-037	49348-037-29

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunmark Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	2023-12-23	Warnings	Exact identifier ndc (package): 49348-037-29 ndc (product): 49348-037 ndc11 (package): 49348003729 spl id: 0d295927-09c8-5b68-e063-6394a90a965f spl set id: 33efa7e9-4c3a-4d72-af31-c5e35095c2ff

Reported adverse events (FAERS/openFDA)#

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