FDA.reportPublic FDA data

Topcare Health Ultra Itch Relief Astringent Eye Drops

Product NDC
36800-855
11-digit product format
368000855
Labeler code
36800
Product ID
36800-855_0cfa87ca-f1d4-c578-e063-6394a90a7626
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl, zinc sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Topco Associates LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
.05; .25 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Ultra Itch Relief Astringent Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL
ZINC SULFATE.25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0YZT43HS7D, 89DS0H96TB
Rxcui1043249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-855-01Topcare Health Ultra Itch Relief Astringent Eye Drops1 in 1 CARTONSOLUTION13
36800-855-01Topcare Health Ultra Itch Relief Astringent Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-855TOPCARE HEALTH ULTRA ITCH RELIEF ASTRINGENT EYE DROPS (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c617e34-fc64-1a5b-e053-2995a90ace2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN9c617e34-fc64-1a5b-e053-2995a90ace2c3
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD9c617e34-fc64-1a5b-e053-2995a90ace2c3
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY9c617e34-fc64-1a5b-e053-2995a90ace2c3
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY9c617e34-fc64-1a5b-e053-2995a90ace2c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-855-01368000855011 BOTTLE, DROPPER in 1 CARTON (36800-855-01) / 15 mL in 1 BOTTLE, DROPPER2020-02-010000-00-00NoNoCurrent