SANIVIR Gel Plus Hand Sanitizer

Product NDC
77396-002
Requested package NDC
77396-002-02
11-digit product format
773960002
Labeler code
77396
Product ID
77396-002_d60d3ecf-b637-4925-e053-2a95a90af57b
Type
HUMAN OTC DRUG
Nonproprietary name
Didecyldimonium Chloride and Benzalkonium Chloride Liquid
Dosage form
GEL
Route
TOPICAL
Labeler
Kemix Quimica, S.A. de C.V.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-13
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE
Active strength
1 mg/.001L; mg/.001L
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage77396-00277396-002-02IInactivated by FDA2026-10-05

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77396-002-012023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer
77396-002-022023-07-28C16284748780-10191ceaa-634e-198a-e063-dbdaa90aec3eSANIVIR Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77396-002-01SANIVIR Gel Plus Hand Sanitizer5 L in 1 BOTTLE, PLASTICGEL55
77396-002-02SANIVIR Gel Plus Hand Sanitizer0.075 L in 1 BOTTLE, PLASTICGEL0.0755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77396-002SANIVIR HANDS, BODY, AND SURFACES SANITIZER (DIDECYLDIMONIUM CHLORIDE AND BENZALKONIUM CHLORIDE LIQUID) LIQUID SANIVIR GEL PLUS HAND SANITIZER (DIDECYLDIMONIUM CHLORIDE AND BENZALKONIUM CHLORIDE LIQUID) GEL [KEMIX QUIMICA, S.A. DE C.V.]5Legacy NDC, 2 package rows20220121_a4e974f4-b6c7-4dab-e053-2995a90add08.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
77396-002-0277396000202.075 L in 1 BOTTLE, PLASTIC (77396-002-02) 2020-05-130000-00-00NoNoCurrent