FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
78019-800
Requested package NDC
78019-800-06
11-digit product format
780190800
Labeler code
78019
Product ID
78019-800_ba65f0f4-baa4-62a2-e053-2995a90af449
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Wenzhou Shengkai Technology Industry Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-29
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 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 packagepackage78019-80078019-800-06IInactivated 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, Related label table
NDCRelated label
78019-800-0178019-800 ​75% Alcohol Hand Sanitizer
78019-800-0278019-800 ​75% Alcohol Hand Sanitizer
78019-800-0378019-800 ​75% Alcohol Hand Sanitizer
78019-800-0478019-800 ​75% Alcohol Hand Sanitizer
78019-800-0578019-800 ​75% Alcohol Hand Sanitizer
78019-800-0678019-800 ​75% Alcohol Hand Sanitizer
78019-800-0778019-800 ​75% Alcohol Hand Sanitizer
78019-800-0878019-800 ​75% Alcohol Hand Sanitizer
78019-800-0978019-800 ​75% Alcohol Hand Sanitizer
78019-800-1078019-800 ​75% Alcohol Hand Sanitizer
78019-800-1178019-800 ​75% Alcohol Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78019-800-01Hand Sanitizer2 mL in 1 BAGGEL22
78019-800-02Hand Sanitizer3 mL in 1 BAGGEL32
78019-800-03Hand Sanitizer5 mL in 1 BAGGEL52
78019-800-04Hand Sanitizer10 mL in 1 BAGGEL102
78019-800-05Hand Sanitizer30 mL in 1 BOTTLEGEL302
78019-800-06Hand Sanitizer60 mL in 1 BOTTLEGEL602
78019-800-07Hand Sanitizer50 mL in 1 BOTTLEGEL502
78019-800-08Hand Sanitizer100 mL in 1 BOTTLEGEL1002
78019-800-09Hand Sanitizer120 mL in 1 BOTTLEGEL1202
78019-800-10Hand Sanitizer250 mL in 1 BOTTLEGEL2502
78019-800-11Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78019-800HAND SANITIZER (ETHYL ALCOHOL) GEL [WENZHOU SHENGKAI TECHNOLOGY INDUSTRY CO., LTD.]2Legacy NDC, 11 package rows20210204_a92e93c1-5183-5fae-e053-2995a90ada20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa92e93c1-5183-5fae-e053-2995a90ada202
1305100ethanol 0.75 ML/ML Topical GelSCDa92e93c1-5183-5fae-e053-2995a90ada202
1305100ethanol 75 % Topical GelSYa92e93c1-5183-5fae-e053-2995a90ada202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78019-800-067801908000660 mL in 1 BOTTLE (78019-800-06) 60 ml2020-06-290000-00-00NoNoCurrent