Santi-Gel Instant Hand Sanitizer

Product NDC
50865-056
Requested package NDC
50865-056-19
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
IngredientStrength
ALCOHOL62.5 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5bb2593-e036-4586-a807-2049e06b2475Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-056-03Santi-Gel Instant Hand Sanitizer208175 mL in 1 DRUMSOLUTION20817513
50865-056-07Santi-Gel Instant Hand Sanitizer3875 mL in 1 BOTTLESOLUTION387513
50865-056-12Santi-Gel Instant Hand Sanitizer1200 mL in 1 BAGSOLUTION120013
50865-056-19Santi-Gel Instant Hand Sanitizer236 mL in 1 BOTTLE, PLASTICSOLUTION23613
50865-056-30Santi-Gel Instant Hand Sanitizer473 mL in 1 BOTTLE, PLASTICSOLUTION47313
50865-056-34Santi-Gel Instant Hand Sanitizer118 mL in 1 BOTTLE, PLASTICSOLUTION11813
50865-056-35Santi-Gel Instant Hand Sanitizer118 mL in 1 BOTTLE, PLASTICSOLUTION11813
50865-056-36Santi-Gel Instant Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION100013
50865-056-38Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-43Santi-Gel Instant Hand Sanitizer236 mL in 1 BOTTLESOLUTION23613
50865-056-65Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-66Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-67Santi-Gel Instant Hand Sanitizer2000 mL in 1 BOTTLESOLUTION200013
50865-056-79Santi-Gel Instant Hand Sanitizer1892 mL in 1 BOTTLE, PUMPSOLUTION189213
50865-056-82Santi-Gel Instant Hand Sanitizer800 mL in 1 BOTTLESOLUTION80013
50865-056-86Santi-Gel Instant Hand Sanitizer800 mL in 1 BAGSOLUTION80013
50865-056-93Santi-Gel Instant Hand Sanitizer1200 mL in 1 BOTTLE, PLASTICSOLUTION120013

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-056SANTI-GEL INSTANT HAND SANITIZER SOLUTION [KUTOL PRODUCTS COMPANY, INC.]13Current NDC, Legacy NDC, 17 package rows20241220_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Santi-Gel Instant Hand SanitizerSANTI-GEL INSTANT HAND SANITIZERKutol Products Company, Inc.f5bb2593-e036-4586-a807-2049e06b24752024-12-18WarningsExact identifier
ndc (package): 50865-056-19
ndc (product): 50865-056
ndc11 (package): 50865005619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50865-056-1950865005619236 mL in 1 BOTTLE, PLASTIC (50865-056-19) 236 ml2013-05-220000-00-00NoNoCurrent