Premier Value Original

Manufacturer: Chain Drug Consortium, LLC
Effective date: 2015-01-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:41:16

Label at a glance#

ProductPremier Value Original

Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE

Label structure12 sections

Storage and handling

Other information some users may experience a brief tingling sensation store at 15° to 25°C (59° to 77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Tetrahydrozoline HCl 0.05%........................... Redness Reliever

OTC - PURPOSE SECTION

Use

for the relief of redness of the eyes due to minor eye irritations

WARNINGS SECTION

Warnings

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye persists
condition worsens or lasts more than 72 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

INDICATIONS & USAGE SECTION

Directions

To open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning
Put 1 to 2 drops in the affected eye(s) up to 4 times daily.

STORAGE AND HANDLING SECTION

Other information

some users may experience a brief tingling sensation
store at 15° to 25°C (59° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients:

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

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	2
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	2
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	2
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	2

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-448-00	2020-01-31	C162847	48780-1	9d75b9cf-e2af-f424-e053-dadaa90a57ce	23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-448-00	Premier Value Original	1 in 1 BOX	SOLUTION/ DROPS	1		2
68016-448-00	Premier Value Original	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-448	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2	Legacy NDC, 2 package rows	20150106_23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-448-00	ML - Milliliter	68016-448	67f2119f-4d12-4f38-9737-24ca873b9d8b	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TETRAHYDROZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0YZT43HS7D	2
TETRAHYDROZOLINE	ACTIVE MOIETY	S9U025Y077	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Premier Value Original
Tetrahydrozoline Hydrochloride
TETRAHYDROZOLINE
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
WATER
SODIUM BORATE
SODIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-448	68016-448-00

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 258 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / OPHTHALMIC		22 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SOFT TISSUE		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	SOLUTION / AURICULAR (OTIC)	0.3 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATUMOR	1.2 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / DENTAL	0.4 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	SUSPENSION/ DROPS / OPHTHALMIC	0.03 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	DROPS / OPHTHALMIC	1 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	SOLUTION/ DROPS / OPHTHALMIC	1.1 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates

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
9c4ac509-75b1-4b20-9a2e-381e997e109f			23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8	2015-01-05	Warnings	Exact identifier spl id: 9c4ac509-75b1-4b20-9a2e-381e997e109f spl set id: 23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8

Reported adverse events (FAERS/openFDA)#

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