Hand Sanitizer

Product NDC
78254-101
Requested package NDC
78254-101-08
11-digit product format
782540101
Labeler code
78254
Product ID
78254-101_af57da32-df96-7870-e053-2995a90a8cbc
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Bozhou Xunhetang Biological Technology Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
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 packagepackage78254-10178254-101-08IInactivated 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 · 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78254-101-01Hand Sanitizer500 mL in 1 BOTTLELIQUID5004
78254-101-02Hand Sanitizer60 mL in 1 BOTTLELIQUID604
78254-101-03Hand Sanitizer100 mL in 1 BOTTLELIQUID1004
78254-101-04Hand Sanitizer300 mL in 1 BOTTLELIQUID3004
78254-101-05Hand Sanitizer500 mL in 1 BOTTLELIQUID5004
78254-101-06Hand Sanitizer30 mL in 1 BOTTLELIQUID304
78254-101-07Hand Sanitizer1000 mL in 1 BOTTLELIQUID10004
78254-101-08Hand Sanitizer3780 mL in 1 BOTTLELIQUID37804
78254-101-09Hand Sanitizer20000 mL in 1 BOTTLELIQUID200004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78254-101HAND SANITIZER (ALCOHOL) LIQUID [BOZHOU XUNHETANG BIOLOGICAL TECHNOLOGY CO., LTD.]4Legacy NDC, 9 package rows20200916_a6223483-7e7c-4695-e053-2995a90a6bd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047755ethanol 75 % Topical SolutionPSNa6223483-7e7c-4695-e053-2995a90a6bd54
1047755ethanol 0.75 ML/ML Topical SolutionSCDa6223483-7e7c-4695-e053-2995a90a6bd54
1047755ethanol 75 % Topical SolutionSYa6223483-7e7c-4695-e053-2995a90a6bd54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78254-101-08782540101083780 mL in 1 BOTTLE (78254-101-08) 3780 ml2020-03-300000-00-00NoNoCurrent