FDA.reportPublic FDA data

Medics Choice Eye Drops Maximum Redness Relief

Product NDC
55651-059
11-digit product format
556510059
Labeler code
55651
Product ID
55651-059_4748ccb8-281a-8c8c-e063-6294a90a908c
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, naphazoline hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
K.C. Pharmaceuticals, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-27
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use if solution changes color or becomes cloudy Ask a doctor before use if you have narrow angle glaucoma When using this product To avoid contamination, do not touch tip of container to any surface Replace cap after using Overuse may produce increased redness of the eye Pupils may become enlarged temporarily Stop use and ask a doctor if you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Medics Choice Eye Drops Maximum Redness Relief
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55651-059-01Medics Choice Eye Drops Maximum Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153
55651-059-01Medics Choice Eye Drops Maximum Redness Relief1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55651-059MEDICS CHOICE EYE DROPS MAXIMUM REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION [K.C. PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20231224_f7131707-47af-d70a-e053-6394a90a418f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSNf7131707-47af-d70a-e053-6394a90a418f3
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCDf7131707-47af-d70a-e053-6394a90a418f3
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSYf7131707-47af-d70a-e053-6394a90a418f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55651-059-01556510059011 BOTTLE, DROPPER in 1 CARTON (55651-059-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-27NoNoCurrent