FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
78784-002
Requested package NDC
78784-002-02
11-digit product format
787840002
Labeler code
78784
Product ID
78784-002_d96ae850-e6b7-eb3e-e053-2a95a90ad6ed
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
GUANGZHOU SLUJ SPECIAL CHEMICAL CO., LTD
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-13
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
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 packagepackage78784-00278784-002-02IInactivated by FDA2026-10-12

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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
78784-002-022024-07-30Instant Hand Sanitizer
78784-002-032024-07-30Instant Hand Sanitizer
78784-002-022024-01-30Instant Hand Sanitizer
78784-002-032024-01-30Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78784-002-02Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78784-002-03Instant Hand Sanitizer1000 mL in 1 BOTTLEGEL10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78784-002INSTANT HAND SANITIZER (ALCOHOL) GEL [GUANGZHOU SLUJ SPECIAL CHEMICAL CO., LTD]3Legacy NDC, 2 package rows20230224_c8adda7d-6a30-7632-e053-2a95a90a1c4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNc8adda7d-6a30-7632-e053-2a95a90a1c4d3
1305100ethanol 0.75 ML/ML Topical GelSCDc8adda7d-6a30-7632-e053-2a95a90a1c4d3
1305100ethanol 75 % Topical GelSYc8adda7d-6a30-7632-e053-2a95a90a1c4d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78784-002-0278784000202500 mL in 1 BOTTLE (78784-002-02) 500 ml2020-06-130000-00-00NoNoCurrent