Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel

Product NDC
77804-005
Requested package NDC
77804-005-02
11-digit product format
778040005
Labeler code
77804
Product ID
77804-005_e26a3aaf-5008-47ed-9c89-8c3c8901a27b
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
KERN SANI, INC.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage77804-00577804-005-02IInactivated by FDA2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77804-005-02Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel236 mL in 1 BOTTLE, PLASTICSOLUTION2361
77804-005-03Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel473 mL in 1 BOTTLE, PLASTICSOLUTION4731
77804-005-04Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel946 mL in 1 BOTTLE, PLASTICSOLUTION9461
77804-005-11Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel3785 mL in 1 BOTTLE, PLASTICSOLUTION37851
77804-005-12Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel18925 mL in 1 JUGSOLUTION189251
77804-005-13Kern Sani, Inc Hand Sanitizer - Lemon Zest Gel189250 mL in 1 DRUMSOLUTION1892501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77804-005KERN SANI, INC HAND SANITIZER - LEMON ZEST GEL (ALCOHOL) SOLUTION [KERN SANI, INC.]1Legacy NDC, 6 package rows20210329_be22b4e0-0b43-4cfb-b82e-504d7733c80c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77804-005-0277804000502236 mL in 1 BOTTLE, PLASTIC (77804-005-02) 236 ml2020-04-300000-00-00NoNoCurrent