FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
77753-002
Requested package NDC
77753-002-03
11-digit product format
777530002
Labeler code
77753
Product ID
77753-002_a715da60-bc6e-2698-e053-2a95a90acfa0
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
SHANDISHI Biological Technology Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage77753-00277753-002-03IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
77753-002-0177753-002 ​Hand Sanitizer
77753-002-0277753-002 ​Hand Sanitizer
77753-002-0377753-002 ​Hand Sanitizer
77753-002-0477753-002 ​Hand Sanitizer
77753-002-0577753-002 ​Hand Sanitizer
77753-002-0677753-002 ​Hand Sanitizer
77753-002-0777753-002 ​Hand Sanitizer
77753-002-0877753-002 ​Hand Sanitizer
77753-002-0977753-002 ​Hand Sanitizer
77753-002-1077753-002 ​Hand Sanitizer
77753-002-1177753-002 ​Hand Sanitizer
77753-002-1277753-002 ​Hand Sanitizer
77753-002-1377753-002 ​Hand Sanitizer
77753-002-1477753-002 ​Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77753-002-01Hand Sanitizer12 in 1 BOXGEL123
77753-002-01Hand Sanitizer10 mL in 1 BOTTLEGEL103
77753-002-02Hand Sanitizer12 in 1 BOXGEL123
77753-002-02Hand Sanitizer15 mL in 1 BOTTLEGEL153
77753-002-03Hand Sanitizer12 in 1 BOXGEL123
77753-002-03Hand Sanitizer30 mL in 1 BOTTLEGEL303
77753-002-04Hand Sanitizer12 in 1 BOXGEL123
77753-002-04Hand Sanitizer53 mL in 1 BOTTLEGEL533
77753-002-05Hand Sanitizer12 in 1 CARTONGEL123
77753-002-05Hand Sanitizer60 mL in 1 BOTTLEGEL603
77753-002-06Hand Sanitizer8 in 1 BOXGEL83
77753-002-06Hand Sanitizer120 mL in 1 BOTTLEGEL1203
77753-002-07Hand Sanitizer8 in 1 BOXGEL83
77753-002-07Hand Sanitizer236 mL in 1 BOTTLEGEL2363
77753-002-08Hand Sanitizer250 mL in 1 BOTTLEGEL2503
77753-002-08Hand Sanitizer8 in 1 BOXGEL83
77753-002-09Hand Sanitizer473 mL in 1 BOTTLEGEL4733
77753-002-09Hand Sanitizer4 in 1 BOXGEL43
77753-002-10Hand Sanitizer500 mL in 1 BOTTLEGEL5003
77753-002-10Hand Sanitizer4 in 1 BOXGEL43
77753-002-11Hand Sanitizer120 mL in 1 BOTTLEGEL1203
77753-002-11Hand Sanitizer12 in 1 BOXGEL123
77753-002-12Hand Sanitizer4 in 1 BOXGEL43
77753-002-12Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
77753-002-13Hand Sanitizer2000 mL in 1 BOTTLEGEL20003
77753-002-13Hand Sanitizer4 in 1 BOXGEL43
77753-002-14Hand Sanitizer4 in 1 BOXGEL43
77753-002-14Hand Sanitizer3780 mL in 1 BOTTLEGEL37803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77753-002HAND SANITIZER (ETHYL ALCOHOL) GEL [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]3Legacy NDC, 28 package rows20200603_a5cdf04d-e27b-e5d8-e053-2995a90a3287.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77753-002-037775300020312 BOTTLE in 1 BOX (77753-002-03) > 30 mL in 1 BOTTLE12 bottle2020-05-200000-00-00NoNoCurrent