Eye Drops

Product NDC
0498-0161
11-digit product format
004980161
Labeler code
0498
Product ID
0498-0161_d3d9ca13-155c-bcae-e053-2995a90a53fe
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline hydrochloride
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
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
0498-0161-15Eye Drops1 in 1 CARTONSOLUTION/ DROPS110
0498-0161-15Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0161EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HONEYWELL SAFETY PRODUCTS USA, INC]10Legacy NDC, 2 package rows20240123_703645d0-5157-7a83-e053-2a91aa0a903e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN703645d0-5157-7a83-e053-2a91aa0a903e10
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD703645d0-5157-7a83-e053-2a91aa0a903e10
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY703645d0-5157-7a83-e053-2a91aa0a903e10
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY703645d0-5157-7a83-e053-2a91aa0a903e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0498-0161-15004980161151 BOTTLE, DROPPER in 1 CARTON (0498-0161-15) > 15 mL in 1 BOTTLE, DROPPER2018-07-040000-00-00NoNoCurrent