KeriCure Hand Sanitizer

Product NDC
78280-302
Requested package NDC
78280-302-04
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78280-30278280-302-04DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1041849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de516d2e-9c16-4bd2-b4c2-7e2f9fd26442Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

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
KeriCure Hand SanitizerALCOHOLKericure Inc.de516d2e-9c16-4bd2-b4c2-7e2f9fd264422025-01-22WarningsExact identifier
ndc (package): 78280-302-04
ndc (product): 78280-302
ndc11 (package): 78280030204

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
78280-302-0478280030204115 mL in 1 BOTTLE, SPRAY (78280-302-04) 115 ml2020-04-102030-12-31NoNoCurrent