Industrial Strength Eye Drops

Product NDC
0498-0162
11-digit product format
004980162
Labeler code
0498
Product ID
0498-0162_d31f18bf-0aa2-6721-e053-2a95a90a6f4e
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline hydrochloride, polyethylene glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Honeywell Safety Products USA, INC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-07-04
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400
Active strength
0 g/100mL; g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0498-0162IInactivated by FDA2026-09-14
excluded packagepackage0498-01620498-0162-15IInactivated by FDA2026-09-14

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
0498-0162-15Industrial Strength Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
0498-0162-15Industrial Strength Eye Drops1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0162INDUSTRIAL STRENGTH EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL) SOLUTION/ DROPS [HONEYWELL SAFETY PRODUCTS USA, INC]7Legacy NDC, 2 package rows20240123_8edb420c-2229-b240-e053-2995a90afc05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN8edb420c-2229-b240-e053-2995a90afc057
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD8edb420c-2229-b240-e053-2995a90afc057
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY8edb420c-2229-b240-e053-2995a90afc057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0498-0162-15004980162151 BOTTLE, DROPPER in 1 CARTON (0498-0162-15) > 15 mL in 1 BOTTLE, DROPPER2018-07-040000-00-00NoNoCurrent