Home NDC 50865-056-07 Santi-Gel Instant Hand Sanitizer
Product NDC 50865-056
Requested package NDC 50865-056-07
11-digit product format 508650056
Labeler code 50865
Product ID 50865-056_298e35b0-1ab3-212b-e063-6394a90a787e
Type HUMAN OTC DRUG
Nonproprietary name Santi-Gel Instant Hand Sanitizer
Dosage form SOLUTION
Route TOPICAL
Labeler Kutol Products Company, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-05-22
Substance ALCOHOL
Active strength 62.5 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 Santi-Gel Instant Hand Sanitizer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 62.5 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 50865-056-03 Santi-Gel Instant Hand Sanitizer 208175 mL in 1 DRUM SOLUTION 208175 13 50865-056-07 Santi-Gel Instant Hand Sanitizer 3875 mL in 1 BOTTLE SOLUTION 3875 13 50865-056-12 Santi-Gel Instant Hand Sanitizer 1200 mL in 1 BAG SOLUTION 1200 13 50865-056-19 Santi-Gel Instant Hand Sanitizer 236 mL in 1 BOTTLE, PLASTIC SOLUTION 236 13 50865-056-30 Santi-Gel Instant Hand Sanitizer 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 13 50865-056-34 Santi-Gel Instant Hand Sanitizer 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 13 50865-056-35 Santi-Gel Instant Hand Sanitizer 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 13 50865-056-36 Santi-Gel Instant Hand Sanitizer 1000 mL in 1 BOTTLE, PLASTIC SOLUTION 1000 13 50865-056-38 Santi-Gel Instant Hand Sanitizer 800 mL in 1 BAG SOLUTION 800 13 50865-056-43 Santi-Gel Instant Hand Sanitizer 236 mL in 1 BOTTLE SOLUTION 236 13 50865-056-65 Santi-Gel Instant Hand Sanitizer 800 mL in 1 BAG SOLUTION 800 13 50865-056-66 Santi-Gel Instant Hand Sanitizer 800 mL in 1 BAG SOLUTION 800 13 50865-056-67 Santi-Gel Instant Hand Sanitizer 2000 mL in 1 BOTTLE SOLUTION 2000 13 50865-056-79 Santi-Gel Instant Hand Sanitizer 1892 mL in 1 BOTTLE, PUMP SOLUTION 1892 13 50865-056-82 Santi-Gel Instant Hand Sanitizer 800 mL in 1 BOTTLE SOLUTION 800 13 50865-056-86 Santi-Gel Instant Hand Sanitizer 800 mL in 1 BAG SOLUTION 800 13 50865-056-93 Santi-Gel Instant Hand Sanitizer 1200 mL in 1 BOTTLE, PLASTIC SOLUTION 1200 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALCOHOL ACTIVE INGREDIENT 3K9958V90M SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 ALCOHOL ACTIVE MOIETY 3K9958V90M SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE, DL- INACTIVE INGREDIENT WR1WPI7EW8 SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 AMINOMETHYLPROPANOL INACTIVE INGREDIENT LU49E6626Q SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 POLYACRYLIC ACID (250000 MW) INACTIVE INGREDIENT 9G2MAD7J6W SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50865-056 SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 13 Current NDC, Legacy NDC, 17 package rows 20241220_f5bb2593-e036-4586-a807-2049e06b2475.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 50865-056-07 50865005607 3875 mL in 1 BOTTLE (50865-056-07) 3875 ml 2019-01-01 0000-00-00 No No Current