TopCare Health Original Eye Drops

Product NDC
36800-858
11-digit product format
368000858
Labeler code
36800
Product ID
36800-858_0cfa5c76-fce8-9f22-e063-6394a90ade89
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Topco Associates LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-06
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Health Original Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0YZT43HS7D
Rxcui1052943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-858-01TopCare Health Original Eye Drops1 in 1 CARTONSOLUTION13
36800-858-01TopCare Health Original Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-858TOPCARE HEALTH ORIGINAL EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c61a56a-c1a9-2846-e053-2995a90a755b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN9c61a56a-c1a9-2846-e053-2995a90a755b3
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD9c61a56a-c1a9-2846-e053-2995a90a755b3
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY9c61a56a-c1a9-2846-e053-2995a90a755b3
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY9c61a56a-c1a9-2846-e053-2995a90a755b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-858-01368000858011 BOTTLE, DROPPER in 1 CARTON (36800-858-01) / 15 mL in 1 BOTTLE, DROPPER2020-02-060000-00-00NoNoCurrent