Equate Eye Drops

Product NDC
67172-282
Requested package NDC
67172-282-01
11-digit product format
671720282
Labeler code
67172
Product ID
67172-282_7569e54f-c70f-4394-a7ea-d8cb65d30fc4
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahyrozoline hydrochloride
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Prestige Brands Holdings, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-11
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
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 packagepackage67172-28267172-282-01DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67172-28267172-282-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-282-01Equate Eye Drops1 in 1 BOXLIQUID17
67172-282-01Equate Eye Drops15 mL in 1 BOTTLE, DROPPERLIQUID157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-282EQUATE EYE DROPS (TETRAHYROZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]7Legacy NDC, 2 package rows20241113_7535168e-907b-4c34-9949-2d1ca6bfe08e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN7535168e-907b-4c34-9949-2d1ca6bfe08e7
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD7535168e-907b-4c34-9949-2d1ca6bfe08e7
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY7535168e-907b-4c34-9949-2d1ca6bfe08e7
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY7535168e-907b-4c34-9949-2d1ca6bfe08e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67172-282-01671720282011 BOTTLE, DROPPER in 1 BOX (67172-282-01) > 15 mL in 1 BOTTLE, DROPPER2013-02-110000-00-00NoNoCurrent