FDA.reportPublic FDA data

Tyson 2.0 Mike Red Eye Drops For Dry High Eyes

Product NDC
84843-0050
11-digit product format
848430050
Labeler code
84843
Product ID
84843-0050_2dc93dea-59ed-e9ab-e063-6294a90af12c
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Naphazoline HCl
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Jbrands Pharma L.L.C.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
.5; .03 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tyson 2.0 Mike Red Eye Drops For Dry High Eyes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.5 g/100mL
NAPHAZOLINE HYDROCHLORIDE.03 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, MZ1131787D
Rxcui1235200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84843-0050-1Tyson 2.0 Mike Red Eye Drops For Dry High Eyes1 in 1 BOXSOLUTION/ DROPS12
84843-0050-1Tyson 2.0 Mike Red Eye Drops For Dry High Eyes15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84843-0050TYSON 2.0 MIKE RED EYE DROPS FOR DRY HIGH EYES (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [JBRANDS PHARMA L.L.C.]2Current NDC, 2 package rows20250212_288e9c85-0562-89bf-e063-6394a90a110d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN288e9c85-0562-89bf-e063-6394a90a110d2
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD288e9c85-0562-89bf-e063-6394a90a110d2
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY288e9c85-0562-89bf-e063-6394a90a110d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84843-0050-1848430050011 BOTTLE, DROPPER in 1 BOX (84843-0050-1) / 15 mL in 1 BOTTLE, DROPPER2025-02-01NoNoHistorical