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_5c433bfd-22f8-9cc8-e063-6294a90a348e
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…
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 Antibacterial Hand Fresh and Clean
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
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
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 2028-02-01 No No Historical 36800-534-56 36800053456 1656 mL in 1 BOTTLE, PLASTIC (36800-534-56) 1656 ml 2019-06-20 0000-00-00 No No Current