FDA.reportPublic FDA data

Clear Eyes

Product NDC
67172-503
Requested package NDC
67172-503-15
11-digit product format
671720503
Labeler code
67172
Product ID
67172-503_09350f1d-8cd8-4e18-965d-6ac85d4b76ce
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride and Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Prestige Brands Holdings, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-01
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; GLYCERIN
Active strength
2 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage67172-50367172-503-15DDiscontinued by firm2026-10-12

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-503-15Clear Eyes Sensitive15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153
67172-503-15Clear Eyes Sensitive1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-503CLEAR EYES SENSITIVE (PHENYLEPHRINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [PRESTIGE BRANDS HOLDINGS, INC.]3Legacy NDC, 2 package rows20240418_ba1e73cf-c43b-4f40-972d-830abbcc1a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2541161glycerin 0.25 % / phenylephrine hydrochloride 0.2 % Ophthalmic SolutionPSNba1e73cf-c43b-4f40-972d-830abbcc1a153
2541161glycerin 2.5 MG/ML / phenylephrine hydrochloride 2 MG/ML Ophthalmic SolutionSCDba1e73cf-c43b-4f40-972d-830abbcc1a153
2541161glycerin 0.25 % / phenylephrine hydrochloride 0.2 % Ophthalmic SolutionSYba1e73cf-c43b-4f40-972d-830abbcc1a153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67172-503-15671720503151 BOTTLE, DROPPER in 1 CARTON (67172-503-15) > 15 mL in 1 BOTTLE, DROPPER2021-05-010000-00-00NoNoCurrent