Home NDC 68400-487 Thick Hand Sanitizer
Product NDC 68400-487
11-digit product format 684000487
Labeler code 68400
Product ID 68400-487_29a58b98-932a-e119-e063-6294a90a0674
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-30
Marketing end 2027-02-19
Substance ALCOHOL
Active strength 70 mL/100mL
NDC exclude flag No
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 Thick Hand Sanitizer 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 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 68400-487-01 Thick Hand Sanitizer 3780 mL in 1 BOTTLE, PLASTIC GEL 3780 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-487 THICK HAND SANITIZER (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 3 Current NDC, Legacy NDC, 1 package rows 20241222_a35b4c26-469b-72ec-e053-2a95a90a0510.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68400-487-01 68400048701 3780 mL in 1 BOTTLE, PLASTIC (68400-487-01) 3780 ml 2020-04-01 2027-02-19 No No Current