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 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLA-S Medication Solutionsc77589fd-f68d-48b7-bd12-51f6b4cc94022024-03-20WarningsExact identifier
application number: M018
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
application number: M018
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
application number: M018
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
application number: M018
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort, CVPTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPSLil' Drug Store Products, Inc.0f50bcc8-3658-8c2c-e063-6294a90a8e132024-01-19WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
application number: M018
Exchange Select Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLArmy and Air Force Exchange Service318bc025-c936-a066-e063-6294a90a47122024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops OriginalTETRAHYDROZOLINE HCLThe Kroger Co.318c17a1-fe08-508b-e063-6394a90a2e082024-01-01WarningsExact identifier
application number: M018
HEB Original Eye DropsTETRAHYDROZOLINE HCLHEB Grocery Company, LP318cb457-bb2d-a1ee-e063-6294a90a80192024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Mart, Inc.318dc92a-0707-d6a4-e063-6294a90ab78a2024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
application number: M018
Harris Teeter Eye Drops OriginalTETRAHYDROZOLINE HCLHarris Teeter, LLC.P31a1b962-27ad-97b1-e063-6294a90a77f12024-01-01WarningsExact identifier
application number: M018
CVP Sterile Eye DropsTETRAHYDROZOLINE HCLSalado Sales, Inc.31a216f8-28e9-ec8f-e063-6394a90aec492024-01-01WarningsExact identifier
application number: M018
Equaline Sterile Eye DropsTETRAHYDROZOLINE HCLUnited Natural Foods, Inc.31a25efb-a627-1a13-e063-6394a90a2ca32024-01-01WarningsExact identifier
application number: M018
Best Choice Eye Drops OriginalTETRAHYDROZOLINE HCLValu Merchandisers Company31a2a42a-bcfe-4f22-e063-6294a90ac60e2024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops OriginalTETRAHYDROZOLINE HCLDiscount Drug Mart, Inc.31a2efb2-3924-6a12-e063-6394a90ab0e22024-01-01WarningsExact identifier
application number: M018
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
application number: M018
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact 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