Home NDC 57337-084-01 Instant Hand Sanitizer
Product NDC 57337-084
Requested package NDC 57337-084-01
11-digit product format 573370084
Labeler code 57337
Product ID 57337-084_2d761e9e-68c0-ffae-e063-6294a90ac509
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler Rejoice International Corp.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-04-25
Substance ALCOHOL
Active strength 62 mL/100mL
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57337-084 57337-084-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57337-084 57337-084-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57337-084 57337-084-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 Instant 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 581660 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 57337-084-01 Instant Hand Sanitizer 53 mL in 1 BOTTLE GEL 53 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-084 INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL CORP.] 4 Current NDC, Legacy NDC, 1 package rows 20250209_4e05cceb-b8f3-48f7-e054-00144ff88e88.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 70 of 114 · 2,277 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 57337-084-01 57337008401 53 mL in 1 BOTTLE (57337-084-01) 53 ml 2017-04-25 0000-00-00 No No Current