Sunmark Eye Drops Original Formula

Product NDC: 49348-037
11-digit product format: 493480037
Labeler code: 49348
Product ID: 49348-037_0d295927-09c8-5b68-e063-6394a90a965f
Type: HUMAN OTC DRUG
Nonproprietary name: Tetrahydrozoline HCl
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Strategic Sourcing Services LLC
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-03-01
Substance: TETRAHYDROZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sunmark Eye Drops Original Formula
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRAHYDROZOLINE HYDROCHLORIDE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0YZT43HS7D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052943	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33efa7e9-4c3a-4d72-af31-c5e35095c2ff	Available on FDA.report

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 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

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

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 5 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Redicare LLC	4d1e5089-22b0-7b3f-e063-6294a90a346a	2026-03-16	Warnings	Exact identifier application number: M018
Leader Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	d7f011a2-05ba-47c3-9519-d31602e105c7	2026-03-12	Warnings	Exact identifier application number: M018
Leader Restorative Formula Lubricant Eye Drops	PROPYLENE GLYCOL	Cardinal Health	87fef7e4-e5a8-4aad-94d2-f80f34826d97	2026-03-12	Warnings	Exact identifier application number: M018
Leader Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Cardinal Health	5c5d6c13-9b51-48f0-8627-b60b0f707fd3	2026-03-12	Warnings	Exact identifier application number: M018
Focus PI	HYPROMELLOSE EYE DROPS 0.7%	COVALENT MEDICAL	e9b2afdd-049a-3987-e053-2a95a90a6cbb	2026-03-09	Warnings	Exact identifier application number: M018
Rain Renewal Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rain Eye Drops, LLC	bb451b22-c4f6-291d-e053-2a95a90a7801	2026-03-06	Warnings	Exact identifier application number: M018
Complete Eye Relief Sterile Lubricant Eye Drops	HYDROXYETHYL CELLULOSE	Similasan Corporation	4c49493a-70f9-0fde-e063-6394a90aea20	2026-03-05	Warnings	Exact identifier application number: M018
Dry Eye Relief Sterile Lubricant Eye Drops	GLYCERIN	Similasan Corporation	4c4cce1c-392e-354d-e063-6294a90a0ca3	2026-03-05	Warnings	Exact identifier application number: M018
Irritated Eye Relief Sterile Lubricant Eye Drops	HYDROXYETHYL CELLULOSE	Similasan Corporation	4c4ddcdf-3037-c9cd-e063-6294a90a16d5	2026-03-05	Warnings	Exact identifier application number: M018
Refresh Optive Mega-3 PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	326cb5d6-c784-404f-9a13-6d69262dda6e	2026-03-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Discount Drug Mart	4ba1b369-54e2-5224-e063-6394a90a4769	2026-02-25	Warnings	Exact identifier application number: M018
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	KC Pharmaceuticals, Inc.	4bafa882-50b7-e3e2-e063-6294a90a76e3	2026-02-25	Warnings	Exact identifier application number: M018
Viva Hydration Boost	GLYCERIN	Nomax Inc	174193b2-65eb-b5fd-e063-6394a90a9cd0	2026-02-10	Warnings	Exact identifier application number: M018
Droptics Performance Eye Drops	NAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOL	Droptics LLC	20fd6822-a7fd-4593-92bb-0a07260893e2	2026-02-09	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Sportpharm LLC	8d58dcbb-72a0-41f0-9eeb-613072a6d7ae	2026-02-06	Warnings	Exact identifier application number: M018
MINIDROPS	LUBRICANT EYE DROPS	Optics Laboratory, Inc	c13c5f91-50df-471c-a7c9-1747a2ac1250	2026-02-03	Warnings	Exact identifier application number: M018
Optase	WHITE PETROLATUM, LANOLIN	Scope Health Inc	c1991caa-51b9-13d1-e053-2995a90a1293	2026-01-31	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	376e0289-28e9-e87f-e063-6294a90a3b04	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	10c3e31d-779d-8ff6-e063-6294a90acd39	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	9e96976b-2990-79e0-e053-2995a90a0f29	2026-01-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0YZT43HS7D	TETRAHYDROZOLINE HYDROCHLORIDE	522-48-5	TETRAHYDROZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	5
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	5
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	5
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-037-29	49348003729	1 BOTTLE, PLASTIC in 1 CARTON (49348-037-29) / 15 mL in 1 BOTTLE, PLASTIC	2007-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunmark Eye Drops Original Formula (PLD)	Strategic Sourcing Services LLC \| KC Pharmaceuticals, Inc.	2023-12-23	HUMAN OTC DRUG LABEL	5