FDA.reportPublic FDA data

GNP Eye Drops Redness and Dry Eye Relief

Product NDC
46122-606
11-digit product format
461220606
Labeler code
46122
Product ID
46122-606_0d291a5f-b636-380c-e063-6394a90a0310
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, naphazoline HCl
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
AmerisourceBergen
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-27
Marketing end
2026-07-31
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
.25; .012 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
GNP Eye Drops Redness and Dry Eye Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.25 g/100mL
NAPHAZOLINE HYDROCHLORIDE.012 g/100mL

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
46122-606-05GNP Eye Drops Redness and Dry Eye Relief1 in 1 CARTONSOLUTION13
46122-606-05GNP Eye Drops Redness and Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-606-05ML - Milliliter46122-606cf8edbce-cdff-4830-a744-bec97b88ae8d12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-606GNP EYE DROPS REDNESS AND DRY EYE RELIEF (GLYCERIN, NAPHAZOLINE HCL) SOLUTION [AMERISOURCEBERGEN]3Current NDC, Legacy NDC, 2 package rows20231224_9b5c8b83-36c5-765b-e053-2995a90a395c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSN9b5c8b83-36c5-765b-e053-2995a90a395c3
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCD9b5c8b83-36c5-765b-e053-2995a90a395c3
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSY9b5c8b83-36c5-765b-e053-2995a90a395c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-606-05461220606051 BOTTLE, DROPPER in 1 CARTON (46122-606-05) / 15 mL in 1 BOTTLE, DROPPER2019-08-270000-00-00NoNoCurrent