FDA.reportPublic FDA data

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
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33efa7e9-4c3a-4d72-af31-c5e35095c2ffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-037-29Sunmark Eye Drops Original Formula15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS155
49348-037-29Sunmark Eye Drops Original Formula1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-037-29ML - Milliliter49348-0373df8703d-582b-4e59-8d43-4c1617217a9512014-10-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-037SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [STRATEGIC SOURCING SERVICES LLC]5Current NDC, Legacy NDC, 2 package rows20240103_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 14 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb479d2ae-4b59-916a-e053-2995a90af8ec2025-11-11WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
application number: M018
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
application number: M018
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
application number: M018
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation3b1834e6-75cf-5380-e063-6294a90ad1d52025-10-25WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim420274c6-7bf0-0920-e063-6294a90a30be2025-10-25WarningsExact identifier
application number: M018
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC797b0394-2f0f-4733-8d20-ec5bdf3e085d2025-10-23WarningsExact identifier
application number: M018
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC661d8764-8ae6-4229-9485-867553ee8e162025-10-23WarningsExact identifier
application number: M018
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
application number: M018
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
application number: M018
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
application number: M018
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
application number: M018
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
application number: M018
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
application number: M018
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
application number: M018
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN33efa7e9-4c3a-4d72-af31-c5e35095c2ff5
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD33efa7e9-4c3a-4d72-af31-c5e35095c2ff5
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY33efa7e9-4c3a-4d72-af31-c5e35095c2ff5
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY33efa7e9-4c3a-4d72-af31-c5e35095c2ff5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49348-037-29493480037291 BOTTLE, PLASTIC in 1 CARTON (49348-037-29) / 15 mL in 1 BOTTLE, PLASTIC2007-03-010000-00-00NoNoCurrent