Home NDC 54983-011 Water-free Antibacterial Hand Sanitizer
Product NDC 54983-011
11-digit product format 549830011
Labeler code 54983
Product ID 54983-011_dd36cd83-ce7a-17fe-e053-2995a90ad207
Type HUMAN OTC DRUG
Nonproprietary name Water-free Antibacterial Hand Sanitizer
Dosage form GEL
Route EXTRACORPOREAL
Labeler Zhejiang Tengyu New Material Technology Co., Ltd.
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-06-03
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 178 mL/237mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 54983-011 I Inactivated by FDA 2026-07-31 excluded package package 54983-011 54983-011-01 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age. on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54983-011-01 Water-free Antibacterial Hand Sanitizer 237 mL in 1 BOTTLE GEL 237 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54983-011 WATER-FREE ANTIBACTERIAL HAND SANITIZER GEL [ZHEJIANG TENGYU NEW MATERIAL TECHNOLOGY CO., LTD.] 2 Legacy NDC, 1 package rows 20220422_a73b9b02-d13f-44e3-e053-2995a90aa606.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54983-011-01 54983001101 237 mL in 1 BOTTLE (54983-011-01) 237 ml 2020-06-03 0000-00-00 No No Current