FDA.reportPublic FDA data

KeriCure Hand Sanitizer

Product NDC
78280-303
11-digit product format
782800303
Labeler code
78280
Product ID
78280-303_3a859c6d-fd08-4d43-b77f-23ffcc00f5d3
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Kericure Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-10
Substance
ALCOHOL
Active strength
70 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
KeriCure Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui1041849

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78280-303-022025-02-01C16284748780-12cef2736-877f-d83d-e063-dadaa90ab31fKeriCure® HAND SANITIZER
78280-303-082025-02-01C16284748780-12cef2736-877f-d83d-e063-dadaa90ab31fKeriCure® HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78280-303-02KeriCure Hand Sanitizer55 mL in 1 BOTTLE, SPRAYSPRAY552
78280-303-08KeriCure Hand Sanitizer230 mL in 1 BOTTLE, SPRAYSPRAY2302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78280-303KERICURE HAND SANITIZER (ALCOHOL) SPRAY [KERICURE INC.]2Current NDC, Legacy NDC, 2 package rows20250202_40d283ad-38a8-4ee6-bcba-56ccb99f7ee6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSN40d283ad-38a8-4ee6-bcba-56ccb99f7ee62
1041849ethanol 0.7 ML/ML Topical SpraySCD40d283ad-38a8-4ee6-bcba-56ccb99f7ee62
1041849ethanol 70 % Topical SpraySY40d283ad-38a8-4ee6-bcba-56ccb99f7ee62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78280-303-027828003030255 mL in 1 BOTTLE, SPRAY (78280-303-02) 55 ml2020-04-100000-00-00NoNoCurrent
78280-303-0878280030308230 mL in 1 BOTTLE, SPRAY (78280-303-08) 230 ml2020-04-100000-00-00NoNoCurrent