FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
77753-003
Requested package NDC
77753-003-03
11-digit product format
777530003
Labeler code
77753
Product ID
77753-003_a6eb36ef-0e36-1454-e053-2995a90a9441
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
SHANDISHI Biological Technology Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-29
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 packagepackage77753-00377753-003-03IInactivated 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
77753-003-0177753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0377753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0477753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0577753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0677753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0777753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0877753-003 ​Hand Sanitizer Alcohol Spray
77753-003-0977753-003 ​Hand Sanitizer Alcohol Spray
77753-003-1077753-003 ​Hand Sanitizer Alcohol Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77753-003-01Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-01Hand Sanitizer10 mL in 1 BOTTLESPRAY102
77753-003-02Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-02Hand Sanitizer15 mL in 1 BOTTLESPRAY152
77753-003-03Hand Sanitizer20 mL in 1 BOTTLESPRAY202
77753-003-03Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-04Hand Sanitizer30 mL in 1 BOTTLESPRAY302
77753-003-04Hand Sanitizer2 in 1 BOXSPRAY22
77753-003-05Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-05Hand Sanitizer50 mL in 1 BOTTLESPRAY502
77753-003-06Hand Sanitizer8 in 1 BOXSPRAY82
77753-003-06Hand Sanitizer60 mL in 1 BOTTLESPRAY602
77753-003-07Hand Sanitizer120 mL in 1 BOTTLESPRAY1202
77753-003-07Hand Sanitizer8 in 1 BOXSPRAY82
77753-003-08Hand Sanitizer8 in 1 BOXSPRAY82
77753-003-08Hand Sanitizer300 mL in 1 BOTTLESPRAY3002
77753-003-09Hand Sanitizer500 mL in 1 BOTTLESPRAY5002
77753-003-09Hand Sanitizer4 in 1 BOXSPRAY42
77753-003-10Hand Sanitizer4 in 1 BOXSPRAY42
77753-003-10Hand Sanitizer1000 mL in 1 BOTTLESPRAY10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77753-003HAND SANITIZER (ETHYL ALCOHOL) SPRAY [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]2Legacy NDC, 20 package rows20200531_a6bf1cb1-1073-94f2-e053-2a95a90ae4af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286295ethanol 75 % Topical SprayPSNa6bf1cb1-1073-94f2-e053-2a95a90ae4af2
2286295ethanol 0.75 ML/ML Topical SpraySCDa6bf1cb1-1073-94f2-e053-2a95a90ae4af2
2286295ethanol 75 % Topical SpraySYa6bf1cb1-1073-94f2-e053-2a95a90ae4af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77753-003-037775300030312 BOTTLE in 1 BOX (77753-003-03) > 20 mL in 1 BOTTLE12 bottle2020-05-290000-00-00NoNoCurrent