FDA.reportPublic FDA data

Discount Drug Mart Eye Drops Multi-Symptom Relief

Product NDC
53943-490
11-digit product format
539430490
Labeler code
53943
Product ID
53943-490_318d8c50-3b6b-d6a8-e063-6294a90ab886
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol 400, Tetrahydrozoline HCl, Zinc sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Discount Drug Mart, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
ZINC SULFATE; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.25; 1; .05 g/100mL; 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 Multi-Symptom Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC SULFATE.25 g/100mL
POLYETHYLENE GLYCOL 4001 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89DS0H96TBInternal UNII lookup
B697894SGQInternal UNII lookup
0YZT43HS7DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2360903Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
318dc92a-0707-d6a4-e063-6294a90ab78aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-490-01Discount Drug Mart Eye Drops Multi-Symptom Relief1 in 1 BOXSOLUTION/ DROPS11
53943-490-01Discount Drug Mart Eye Drops Multi-Symptom Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-490DISCOUNT DRUG MART EYE DROPS MULTI-SYMPTOM RELIEF (POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [DISCOUNT DRUG MART, INC.]1Current NDC, 2 package rows20250402_318dc92a-0707-d6a4-e063-6294a90ab78a.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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
application number: M018
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
application number: M018
Visine A.C. Itchy Eye ReliefTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC257b9666-0163-499b-9673-bf6f4d6899b12024-11-13WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
application number: M018
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
application number: M018
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
application number: M018
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
application number: M018
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN318dc92a-0707-d6a4-e063-6294a90ab78a1
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD318dc92a-0707-d6a4-e063-6294a90ab78a1
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY318dc92a-0707-d6a4-e063-6294a90ab78a1
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY318dc92a-0707-d6a4-e063-6294a90ab78a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53943-490-01539430490011 BOTTLE, DROPPER in 1 BOX (53943-490-01) / 15 mL in 1 BOTTLE, DROPPER2024-01-01NoNoCurrent