Home NDC 36800-534 TopCare Antibacterial Hand Fresh and Clean
Product NDC 36800-534
11-digit product format 368000534
Labeler code 36800
Product ID 36800-534_50db7527-3f0e-8b42-e063-6394a90a4f74
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride
Dosage form LIQUID
Route TOPICAL
Labeler Topco Associates LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-20
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 36800-534-56 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 36800-534-56 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 36800-534-56 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 36800-534-56 8dfbde2a14a4…c9ff85d89658…
Additional Listing Data#
Finished product Yes
Brand name base TopCare Antibacterial Hand Fresh and Clean
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046593 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-534-50 TopCare Antibacterial Hand Fresh and Clean 1470 mL in 1 BOTTLE, PLASTIC LIQUID 1470 9 36800-534-56 TopCare Antibacterial Hand Fresh and Clean 1656 mL in 1 BOTTLE, PLASTIC LIQUID 1656 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-534 TOPCARE ANTIBACTERIAL HAND FRESH AND CLEAN (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240510_182a9b33-1b40-4a8b-8a89-210ce1483205.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-534-50 36800053450 1470 mL in 1 BOTTLE, PLASTIC (36800-534-50) 1470 ml 2023-06-01 No No Current 36800-534-56 36800053456 1656 mL in 1 BOTTLE, PLASTIC (36800-534-56) 1656 ml 2019-06-20 0000-00-00 No No Current