Home NDC 36800-858 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TopCare Health Original Eye Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0YZT43HS7D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1052943 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-858-01 TopCare Health Original Eye Drops 1 in 1 CARTON SOLUTION 1 3 36800-858-01 TopCare Health Original Eye Drops 15 mL in 1 BOTTLE, DROPPER SOLUTION 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-858 TOPCARE HEALTH ORIGINAL EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231221_9c61a56a-c1a9-2846-e053-2995a90a755b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-858-01 36800085801 1 BOTTLE, DROPPER in 1 CARTON (36800-858-01) / 15 mL in 1 BOTTLE, DROPPER 2020-02-06 0000-00-00 No No Current