FDA.reportPublic FDA data

GNP Eye Drops Redness and Dry Eye Relief

Product NDC
46122-606
Requested package NDC
46122-606-05
11-digit product format
461220606
Labeler code
46122
Product ID
46122-606_9b5c8b83-36c6-765b-e053-2995a90a395c
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, naphazoline HCl
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
AmerisourceBergen
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-01-05
Marketing end
0000-00-00
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
0 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-60646122-606-05DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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]3Legacy 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, DROPPER2020-01-050000-00-00NoNoCurrent