FDA.reportPublic FDA data

DermaCen Instant Hand Sanitizer

Product NDC
62654-140
11-digit product format
626540140
Labeler code
62654
Product ID
62654-140_28d9a546-83a5-2d50-e063-6394a90a3428
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Central Solutions Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-01-01
Substance
ALCOHOL
Active strength
64.5 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DermaCen Instant Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL64.5 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui1100016

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62654-140-02DermaCen Instant Hand Sanitizer236 mL in 1 BOTTLE, PLASTICLIQUID2363
62654-140-03DermaCen Instant Hand Sanitizer443 mL in 1 BOTTLE, PLASTICLIQUID4433
62654-140-36DermaCen Instant Hand Sanitizer800 mL in 1 BOTTLE, PLASTICLIQUID8003
62654-140-90DermaCen Instant Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10003
62654-140-91DermaCen Instant Hand Sanitizer1000 mL in 1 BOTTLELIQUID10003
62654-140-92DermaCen Instant Hand Sanitizer1250 mL in 1 BOTTLE, PLASTICLIQUID12503
62654-140-93DermaCen Instant Hand Sanitizer2000 mL in 1 BOTTLELIQUID20003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90MDERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1
AlcoholACTIVE MOIETY3K9958V90MDERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))INACTIVE INGREDIENT59TL3WG5CODERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0DERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62654-140DERMACEN INSTANT HAND SANITIZER (ALCOHOL) LIQUID [CENTRAL SOLUTIONS INC]3Current NDC, Legacy NDC, 7 package rows20241210_36783d30-a222-40fe-a5ea-61a2842a34c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100016ethanol 64.5 % Topical SolutionPSN36783d30-a222-40fe-a5ea-61a2842a34c93
1100016ethanol 0.645 ML/ML Topical SolutionSCD36783d30-a222-40fe-a5ea-61a2842a34c93
1100016ethanol 64.5 % Topical SolutionSY36783d30-a222-40fe-a5ea-61a2842a34c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62654-140-0262654014002236 mL in 1 BOTTLE, PLASTIC (62654-140-02) 236 ml2018-12-050000-00-00NoNoCurrent
62654-140-0362654014003443 mL in 1 BOTTLE, PLASTIC (62654-140-03) 443 ml2018-12-050000-00-00NoNoCurrent
62654-140-3662654014036800 mL in 1 BOTTLE, PLASTIC (62654-140-36) 800 ml2018-12-050000-00-00NoNoCurrent
62654-140-90626540140901000 mL in 1 BOTTLE, PLASTIC (62654-140-90) 1000 ml2018-12-050000-00-00NoNoCurrent
62654-140-91626540140911000 mL in 1 BOTTLE (62654-140-91) 1000 ml2018-12-050000-00-00NoNoCurrent
62654-140-92626540140921250 mL in 1 BOTTLE, PLASTIC (62654-140-92) 1250 ml2018-12-050000-00-00NoNoCurrent
62654-140-93626540140932000 mL in 1 BOTTLE (62654-140-93) 2000 ml2018-12-050000-00-00NoNoCurrent