FDA.reportPublic FDA data

Discount Drug Mart Eye Drops A.C.

Product NDC
53943-062
11-digit product format
539430062
Labeler code
53943
Product ID
53943-062_47451eaa-897d-aa74-e063-6394a90ae040
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl, zinc sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Discount Drug Mart
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-22
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
.05; .25 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Discount Drug Mart Eye Drops A.C.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL
ZINC SULFATE.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal UNII lookup
89DS0H96TBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043249Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5f1d3da-5300-8211-e053-2a95a90a323aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-062-01Discount Drug Mart Eye Drops A.C.1 in 1 CARTONSOLUTION13
53943-062-01Discount Drug Mart Eye Drops A.C.15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-062DISCOUNT DRUG MART EYE DROPS A.C. (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [DISCOUNT DRUG MART]2Current NDC, 2 package rows20231224_f5f1d3da-5300-8211-e053-2a95a90a323a.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
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSNf5f1d3da-5300-8211-e053-2a95a90a323a3
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCDf5f1d3da-5300-8211-e053-2a95a90a323a3
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSYf5f1d3da-5300-8211-e053-2a95a90a323a3
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSYf5f1d3da-5300-8211-e053-2a95a90a323a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53943-062-01539430062011 BOTTLE, DROPPER in 1 CARTON (53943-062-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-22NoNoCurrent