FDA.reportPublic FDA data

Sani-Kure Extra Strength Hand Sanitizer

Product NDC
78923-001
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.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct78923-001IInactivated by FDA2026-07-31
excluded productproduct78923-001IInactivated by FDA2026-07-31
excluded productproduct78923-001IInactivated by FDA2026-07-31
excluded packagepackage78923-00178923-001-02IInactivated by FDA2026-07-31
excluded packagepackage78923-00178923-001-04IInactivated by FDA2026-07-31
excluded packagepackage78923-00178923-001-08IInactivated by FDA2026-07-31
excluded packagepackage78923-00178923-001-32IInactivated by FDA2026-07-31
excluded packagepackage78923-00178923-001-38IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
KONIX Alcohol Antiseptic Hand RubKONIX ALCOHOL ANTISEPTIC HAND RUBTURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS17435b35-815b-4292-a809-e533ea137b802025-01-29WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsExact identifier
HandLOTIONDerma Gloveba9611a3-e2a4-4835-9ffe-aafe85a7cb9c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove45d130c9-0835-45bb-b525-86a2119c87d12024-10-09WarningsExact identifier
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

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
78923-001-027892300010259 mL in 1 BOTTLE, SPRAY (78923-001-02) 59 ml2020-03-300000-00-00NoNoCurrent
78923-001-0478923000104118 mL in 1 BOTTLE, SPRAY (78923-001-04) 118 ml2020-03-300000-00-00NoNoCurrent
78923-001-0878923000108236 mL in 1 BOTTLE, SPRAY (78923-001-08) 236 ml2020-03-300000-00-00NoNoCurrent
78923-001-3278923000132946 mL in 1 BOTTLE, SPRAY (78923-001-32) 946 ml2020-03-300000-00-00NoNoCurrent
78923-001-38789230001383800 mL in 1 BOTTLE, SPRAY (78923-001-38) 3800 ml2020-03-300000-00-00NoNoCurrent