FDA.reportPublic FDA data

Harris Teeter Eye Drops Maximum Redness Relief

Product NDC
69256-058
11-digit product format
692560058
Labeler code
69256
Product ID
69256-058_47491040-0b86-ee67-e063-6294a90a47d4
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, naphazoline hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Harris Teeter, LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-24
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
Harris Teeter 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
69256-058-01Harris Teeter Eye Drops Maximum Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153
69256-058-01Harris Teeter Eye Drops Maximum Redness Relief1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-058HARRIS TEETER EYE DROPS MAXIMUM REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION [HARRIS TEETER, LLC]2Current NDC, 2 package rows20231224_f710d107-0403-21c5-e053-6394a90a0372.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSNf710d107-0403-21c5-e053-6394a90a03723
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCDf710d107-0403-21c5-e053-6394a90a03723
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSYf710d107-0403-21c5-e053-6394a90a03723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69256-058-01692560058011 BOTTLE, DROPPER in 1 CARTON (69256-058-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-24NoNoHistorical