FDA.reportPublic FDA data

GNP Eye Drops Seasonal Relief

Product NDC
46122-602
11-digit product format
461220602
Labeler code
46122
Product ID
46122-602_9b11b129-7788-8a9d-e053-2995a90a45fe
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl, zinc sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
AmerisourceBergen
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-01-04
Marketing end
0000-00-00
Substance
ZINC SULFATE; TETRAHYDROZOLINE 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46122-602DDiscontinued by firm2026-10-05
excluded packagepackage46122-60246122-602-05DDiscontinued 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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-602-05GNP Eye Drops Seasonal Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153
46122-602-05GNP Eye Drops Seasonal Relief1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-602-05ML - Milliliter46122-602bc344282-903d-47f4-8972-4a1a6b03f94a12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-602GNP EYE DROPS SEASONAL RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [AMERISOURCEBERGEN]3Legacy NDC, 2 package rows20231224_9b11b129-7787-8a9d-e053-2995a90a45fe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-602-05461220602051 BOTTLE, DROPPER in 1 CARTON (46122-602-05) > 15 mL in 1 BOTTLE, DROPPER2020-01-040000-00-00NoNoCurrent