FDA.reportPublic FDA data

KeriCure Hand Sanitizer

Product NDC
78280-302
11-digit product format
782800302
Labeler code
78280
Product ID
78280-302_6d220d4b-a2a9-488c-b38f-360a4e3b57ff
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78280-302-012025-02-01C16284748780-12cef2736-7e00-d83d-e063-dadaa90ab31fKeriCure ® HAND SANITIZER
78280-302-022025-02-01C16284748780-12cef2736-7e00-d83d-e063-dadaa90ab31fKeriCure ® HAND SANITIZER
78280-302-042025-02-01C16284748780-12cef2736-7e00-d83d-e063-dadaa90ab31fKeriCure ® HAND SANITIZER
78280-302-082025-02-01C16284748780-12cef2736-7e00-d83d-e063-dadaa90ab31fKeriCure ® HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78280-302-01KeriCure Hand Sanitizer28 mL in 1 BOTTLE, SPRAYSPRAY283
78280-302-02KeriCure Hand Sanitizer55 mL in 1 BOTTLE, SPRAYSPRAY553
78280-302-04KeriCure Hand Sanitizer115 mL in 1 BOTTLE, SPRAYSPRAY1153
78280-302-08KeriCure Hand Sanitizer230 mL in 1 BOTTLE, SPRAYSPRAY2303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78280-302KERICURE HAND SANITIZER (ALCOHOL) SPRAY [KERICURE INC.]3Current NDC, Legacy NDC, 4 package rows20250202_de516d2e-9c16-4bd2-b4c2-7e2f9fd26442.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSNde516d2e-9c16-4bd2-b4c2-7e2f9fd264423
1041849ethanol 0.7 ML/ML Topical SpraySCDde516d2e-9c16-4bd2-b4c2-7e2f9fd264423
1041849ethanol 70 % Topical SpraySYde516d2e-9c16-4bd2-b4c2-7e2f9fd264423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78280-302-017828003020128 mL in 1 BOTTLE, SPRAY (78280-302-01) 28 ml2020-04-100000-00-00NoNoCurrent
78280-302-027828003020255 mL in 1 BOTTLE, SPRAY (78280-302-02) 55 ml2020-04-100000-00-00NoNoCurrent
78280-302-0478280030204115 mL in 1 BOTTLE, SPRAY (78280-302-04) 115 ml2020-04-100000-00-00NoNoCurrent
78280-302-0878280030208230 mL in 1 BOTTLE, SPRAY (78280-302-08) 230 ml2020-04-100000-00-00NoNoCurrent