Home NDC 53863-002-04 Hand Sanitizer
Product NDC 53863-002
Requested package NDC 53863-002-04
11-digit product format 538630002
Labeler code 53863
Product ID 53863-002_1c250982-7ac2-a037-e063-6294a90ad6f6
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler Exelencia Importers, Corp.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-03
Substance ALCOHOL
Active strength 70 mL/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 Hand Sanitizer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 70 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 581662 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53863-002-01 Hand Sanitizer 50 mL in 1 BOTTLE GEL 50 4 53863-002-02 Hand Sanitizer 200 mL in 1 BOTTLE GEL 200 4 53863-002-03 Hand Sanitizer 250 mL in 1 BOTTLE GEL 250 4 53863-002-04 Hand Sanitizer 475 mL in 1 BOTTLE GEL 475 4 53863-002-05 Hand Sanitizer 4000 mL in 1 BOTTLE GEL 4000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53863-002 HAND SANITIZER (ETHYL ALCOHOL) GEL [EXELENCIA IMPORTERS, CORP.] 4 Current NDC, Legacy NDC, 5 package rows 20240708_abffec96-20e5-fd78-e053-2a95a90a4b08.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 53863-002-04 53863000204 475 mL in 1 BOTTLE (53863-002-04) 475 ml 2020-08-03 0000-00-00 No No Current