FDA.reportPublic FDA data

Sani-Kure Extra Strength Hand Sanitizer

Product NDC
78923-001
Requested package NDC
78923-001-08
11-digit product format
789230001
Labeler code
78923
Product ID
78923-001_d5f4878d-f211-a454-e053-2995a90a700b
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
KOLORCURE CORPORATION
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
74 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78923-00178923-001-08IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78923-001-022023-07-28C16284748780-10191ceaa-6cca-198a-e063-dbdaa90aec3ea7c04185-d309-931b-e053-2a95a90ac783
78923-001-042023-07-28C16284748780-10191ceaa-6884-198a-e063-dbdaa90aec3ea932b278-ee8a-c37a-e053-2995a90aa2a1
78923-001-082023-07-28C16284748780-10191ceaa-6884-198a-e063-dbdaa90aec3ea932b278-ee8a-c37a-e053-2995a90aa2a1
78923-001-322023-07-28C16284748780-10191ceaa-6afb-198a-e063-dbdaa90aec3eab65d627-2c5a-b64e-e053-2a95a90a335d
78923-001-382023-07-28C16284748780-10191ceaa-6afb-198a-e063-dbdaa90aec3eab65d627-2c5a-b64e-e053-2a95a90a335d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78923-001-32Sani-Kure Extra Strength Hand Sanitizer946 mL in 1 BOTTLE, SPRAYSOLUTION9463
78923-001-38Sani-Kure Extra Strength Hand Sanitizer3800 mL in 1 BOTTLE, SPRAYSOLUTION38003
78923-001-02Sani-Kure Extra Strength Hand Sanitizer59 mL in 1 BOTTLE, SPRAYSOLUTION592
78923-001-04Sani-Kure Extra Strength Hand Sanitizer118 mL in 1 BOTTLE, SPRAYSOLUTION1182
78923-001-08Sani-Kure Extra Strength Hand Sanitizer236 mL in 1 BOTTLE, SPRAYSOLUTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78923-001SANI-KURE EXTRA STRENGTH HAND SANITIZER (ALCOHOL) SOLUTION [KOLORCURE CORPORATION]3Legacy NDC, 2 package rows20220120_ab65d627-2c5a-b64e-e053-2a95a90a335d.zip
78923-001SANI-KURE EXTRA STRENGTH HAND SANITIZER (ALCOHOL) SOLUTION [KOLORCURE CORPORATION]2Legacy NDC, 1 package rows20220120_a7c04185-d309-931b-e053-2a95a90ac783.zip
78923-001SANI-KURE EXTRA STRENGTH HAND SANITIZER (ALCOHOL) SOLUTION [KOLORCURE CORPORATION]2Legacy NDC, 2 package rows20220120_a932b278-ee8a-c37a-e053-2995a90aa2a1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78923-001-0878923000108236 mL in 1 BOTTLE, SPRAY (78923-001-08) 236 ml2020-03-300000-00-00NoNoCurrent