FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
78445-101
Requested package NDC
78445-101-02
11-digit product format
784450101
Labeler code
78445
Product ID
78445-101_cad3c01c-6d72-2e10-e053-2a95a90a848d
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Kangfei Cosmetics 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
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 packagepackage78445-10178445-101-02IInactivated 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 · 16 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…

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
78445-101-012022-07-29Hand Sanitizer
78445-101-022022-07-29Hand Sanitizer
78445-101-032022-07-29Hand Sanitizer
78445-101-042022-07-29Hand Sanitizer
78445-101-052022-07-29Hand Sanitizer
78445-101-062022-07-29Hand Sanitizer
78445-101-072022-07-29Hand Sanitizer
78445-101-082022-07-29Hand Sanitizer
78445-101-092022-07-29Hand Sanitizer
78445-101-102022-07-29Hand Sanitizer
78445-101-112022-07-29Hand Sanitizer
78445-101-122022-07-29Hand Sanitizer
78445-101-132022-07-29Hand Sanitizer
78445-101-142022-07-29Hand Sanitizer
78445-101-152022-07-29Hand Sanitizer
78445-101-162022-07-29Hand Sanitizer
78445-101-172022-07-29Hand Sanitizer
78445-101-182022-07-29Hand Sanitizer
78445-101-192022-07-29Hand Sanitizer
78445-101-202022-07-29Hand Sanitizer
78445-101-212022-07-29Hand Sanitizer
78445-101-222022-07-29Hand Sanitizer
78445-101-232022-07-29Hand Sanitizer
78445-101-242022-07-29Hand Sanitizer
78445-101-252022-07-29Hand Sanitizer
78445-101-262022-07-29Hand Sanitizer
78445-101-272022-07-29Hand Sanitizer
78445-101-282022-07-29Hand Sanitizer
78445-101-292022-07-29Hand Sanitizer
78445-101-302022-07-29Hand Sanitizer
78445-101-312022-07-29Hand Sanitizer
78445-101-322022-07-29Hand Sanitizer
78445-101-332022-07-29Hand Sanitizer
78445-101-342022-07-29Hand Sanitizer
78445-101-352022-07-29Hand Sanitizer
78445-101-362022-07-29Hand Sanitizer
78445-101-372022-07-29Hand Sanitizer
78445-101-382022-07-29Hand Sanitizer
78445-101-392022-07-29Hand Sanitizer
78445-101-402022-07-29Hand Sanitizer
78445-101-412022-07-29Hand Sanitizer
78445-101-422022-07-29Hand Sanitizer
78445-101-432022-07-29Hand Sanitizer
78445-101-442022-07-29Hand Sanitizer
78445-101-452022-07-29Hand Sanitizer
78445-101-012021-08-31Hand Sanitizer
78445-101-022021-08-31Hand Sanitizer
78445-101-032021-08-31Hand Sanitizer
78445-101-042021-08-31Hand Sanitizer
78445-101-052021-08-31Hand Sanitizer
78445-101-062021-08-31Hand Sanitizer
78445-101-072021-08-31Hand Sanitizer
78445-101-082021-08-31Hand Sanitizer
78445-101-092021-08-31Hand Sanitizer
78445-101-102021-08-31Hand Sanitizer
78445-101-112021-08-31Hand Sanitizer
78445-101-122021-08-31Hand Sanitizer
78445-101-132021-08-31Hand Sanitizer
78445-101-142021-08-31Hand Sanitizer
78445-101-152021-08-31Hand Sanitizer
78445-101-162021-08-31Hand Sanitizer
78445-101-172021-08-31Hand Sanitizer
78445-101-182021-08-31Hand Sanitizer
78445-101-192021-08-31Hand Sanitizer
78445-101-202021-08-31Hand Sanitizer
78445-101-212021-08-31Hand Sanitizer
78445-101-222021-08-31Hand Sanitizer
78445-101-232021-08-31Hand Sanitizer
78445-101-242021-08-31Hand Sanitizer
78445-101-252021-08-31Hand Sanitizer
78445-101-262021-08-31Hand Sanitizer
78445-101-272021-08-31Hand Sanitizer
78445-101-282021-08-31Hand Sanitizer
78445-101-292021-08-31Hand Sanitizer
78445-101-302021-08-31Hand Sanitizer
78445-101-312021-08-31Hand Sanitizer
78445-101-322021-08-31Hand Sanitizer
78445-101-332021-08-31Hand Sanitizer
78445-101-342021-08-31Hand Sanitizer
78445-101-352021-08-31Hand Sanitizer
78445-101-362021-08-31Hand Sanitizer
78445-101-372021-08-31Hand Sanitizer
78445-101-382021-08-31Hand Sanitizer
78445-101-392021-08-31Hand Sanitizer
78445-101-402021-08-31Hand Sanitizer
78445-101-412021-08-31Hand Sanitizer
78445-101-422021-08-31Hand Sanitizer
78445-101-432021-08-31Hand Sanitizer
78445-101-442021-08-31Hand Sanitizer
78445-101-452021-08-31Hand Sanitizer
78445-101-012021-07-23Hand Sanitizer
78445-101-022021-07-23Hand Sanitizer
78445-101-032021-07-23Hand Sanitizer
78445-101-042021-07-23Hand Sanitizer
78445-101-052021-07-23Hand Sanitizer
78445-101-062021-07-23Hand Sanitizer
78445-101-072021-07-23Hand Sanitizer
78445-101-082021-07-23Hand Sanitizer
78445-101-092021-07-23Hand Sanitizer
78445-101-102021-07-23Hand Sanitizer
78445-101-112021-07-23Hand Sanitizer
78445-101-122021-07-23Hand Sanitizer
78445-101-132021-07-23Hand Sanitizer
78445-101-142021-07-23Hand Sanitizer
78445-101-152021-07-23Hand Sanitizer
78445-101-162021-07-23Hand Sanitizer
78445-101-172021-07-23Hand Sanitizer
78445-101-182021-07-23Hand Sanitizer
78445-101-192021-07-23Hand Sanitizer
78445-101-202021-07-23Hand Sanitizer
78445-101-212021-07-23Hand Sanitizer
78445-101-222021-07-23Hand Sanitizer
78445-101-232021-07-23Hand Sanitizer
78445-101-242021-07-23Hand Sanitizer
78445-101-252021-07-23Hand Sanitizer
78445-101-262021-07-23Hand Sanitizer
78445-101-272021-07-23Hand Sanitizer
78445-101-282021-07-23Hand Sanitizer
78445-101-292021-07-23Hand Sanitizer
78445-101-302021-07-23Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78445-101-01Hand Sanitizer30 mL in 1 BOTTLEGEL303
78445-101-02Hand Sanitizer60 mL in 1 BOTTLEGEL603
78445-101-03Hand Sanitizer300 mL in 1 BOTTLEGEL3003
78445-101-04Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78445-101-05Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
78445-101-06Hand Sanitizer2500 mL in 1 BOTTLEGEL25003
78445-101-07Hand Sanitizer2.5 mL in 1 BOTTLEGEL2.53
78445-101-08Hand Sanitizer2000 mL in 1 BOTTLEGEL20003
78445-101-09Hand Sanitizer2 mL in 1 BOTTLEGEL23
78445-101-10Hand Sanitizer3800 mL in 1 BOTTLEGEL38003
78445-101-11Hand Sanitizer3000 mL in 1 BOTTLEGEL30003
78445-101-12Hand Sanitizer3 mL in 1 BOTTLEGEL33
78445-101-13Hand Sanitizer4000 mL in 1 BOTTLEGEL40003
78445-101-14Hand Sanitizer4 mL in 1 BOTTLEGEL43
78445-101-15Hand Sanitizer5000 mL in 1 BOTTLEGEL50003
78445-101-16Hand Sanitizer5 mL in 1 BOTTLEGEL53
78445-101-17Hand Sanitizer6000 mL in 1 BOTTLEGEL60003
78445-101-18Hand Sanitizer6 mL in 1 BOTTLEGEL63
78445-101-19Hand Sanitizer7600 mL in 1 BOTTLEGEL76003
78445-101-20Hand Sanitizer8000 mL in 1 BOTTLEGEL80003
78445-101-21Hand Sanitizer8 mL in 1 BOTTLEGEL83
78445-101-22Hand Sanitizer9 mL in 1 BOTTLEGEL93
78445-101-23Hand Sanitizer10000 mL in 1 BOTTLEGEL100003
78445-101-24Hand Sanitizer10 mL in 1 BOTTLEGEL103
78445-101-25Hand Sanitizer15000 mL in 1 BOTTLEGEL150003
78445-101-26Hand Sanitizer15 mL in 1 BOTTLEGEL153
78445-101-27Hand Sanitizer19000 mL in 1 BOTTLEGEL190003
78445-101-28Hand Sanitizer20000 mL in 1 BOTTLEGEL200003
78445-101-29Hand Sanitizer20 mL in 1 BOTTLEGEL203
78445-101-30Hand Sanitizer25000 mL in 1 BOTTLEGEL250003
78445-101-31Hand Sanitizer38000 mL in 1 BOTTLEGEL380003
78445-101-32Hand Sanitizer50 mL in 1 BOTTLEGEL503
78445-101-33Hand Sanitizer59 mL in 1 BOTTLEGEL593
78445-101-34Hand Sanitizer60 mL in 1 BOTTLEGEL603
78445-101-35Hand Sanitizer80 mL in 1 BOTTLEGEL803
78445-101-36Hand Sanitizer100 mL in 1 BOTTLEGEL1003
78445-101-37Hand Sanitizer120 mL in 1 BOTTLEGEL1203
78445-101-38Hand Sanitizer200 mL in 1 BOTTLEGEL2003
78445-101-39Hand Sanitizer236 mL in 1 BOTTLEGEL2363
78445-101-40Hand Sanitizer250 mL in 1 BOTTLEGEL2503
78445-101-41Hand Sanitizer300 mL in 1 BOTTLEGEL3003
78445-101-42Hand Sanitizer350 mL in 1 BOTTLEGEL3503
78445-101-43Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78445-101-44Hand Sanitizer30 mL in 1 BOTTLEGEL303
78445-101-45Hand Sanitizer30 mL in 1 BOTTLEGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78445-101HAND SANITIZER (ALCOHOL) GEL [GUANGZHOU KANGFEI COSMETICS CO., LTD.]3Legacy NDC, 45 package rows20210901_a7138fdd-a1cf-03f6-e053-2a95a90a2a9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa7138fdd-a1cf-03f6-e053-2a95a90a2a9e3
1305100ethanol 0.75 ML/ML Topical GelSCDa7138fdd-a1cf-03f6-e053-2a95a90a2a9e3
1305100ethanol 75 % Topical GelSYa7138fdd-a1cf-03f6-e053-2a95a90a2a9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78445-101-027844501010260 mL in 1 BOTTLE (78445-101-02) 60 ml2020-03-300000-00-00NoNoCurrent