Home NDC 83165-000 Antiseptic Hand Sanitizer
Product NDC 83165-000
11-digit product format 831650000
Labeler code 83165
Product ID 83165-000_52e1fab7-3ecd-821d-e063-6394a90a454a
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form LIQUID
Route TOPICAL
Labeler Hubei Fanjian Medical Product Co.,Ltd
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-07
Substance ALCOHOL
Active strength 62 mL/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Antiseptic Hand Sanitizer
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 62 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 247835 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83165-000-00 Antiseptic Hand Sanitizer 1.03 mL in 1 BOTTLE LIQUID 1.03 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83165-000 ANTISEPTIC HAND SANITIZER (ALCOHOL) LIQUID [HUBEI FANJIAN MEDICAL PRODUCT CO.,LTD] 3 Current NDC, 1 package rows 20231111_9b4014a3-6296-4628-9cc6-b8d4ef4a25f3.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 Sample Exclude flag Status 83165-000-00 83165000000 1.03 mL in 1 BOTTLE (83165-000-00) 1.03 ml 2023-01-07 No No Current