FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
78403-001
Requested package NDC
78403-001-01
11-digit product format
784030001
Labeler code
78403
Product ID
78403-001_a686ed26-7f57-722b-e053-2995a90a1682
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Cangty Biotechnology Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-16
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 packagepackage78403-00178403-001-01IInactivated 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 · 19 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…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
78403-001-01HAND SANITIZER
78403-001-02HAND SANITIZER
78403-001-03HAND SANITIZER
78403-001-04HAND SANITIZER
78403-001-05HAND SANITIZER
78403-001-06HAND SANITIZER
78403-001-07HAND SANITIZER
78403-001-08HAND SANITIZER
78403-001-09HAND SANITIZER
78403-001-10HAND SANITIZER
78403-001-11HAND SANITIZER
78403-001-12HAND SANITIZER
78403-001-13HAND SANITIZER
78403-001-14HAND SANITIZER
78403-001-15HAND SANITIZER
78403-001-16HAND SANITIZER
78403-001-17HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78403-001-01Hand Sanitizer5 mL in 1 BOTTLEGEL51
78403-001-02Hand Sanitizer10 mL in 1 BOTTLEGEL101
78403-001-03Hand Sanitizer15 mL in 1 BOTTLEGEL151
78403-001-04Hand Sanitizer30 mL in 1 BOTTLEGEL301
78403-001-05Hand Sanitizer50 mL in 1 BOTTLEGEL501
78403-001-06Hand Sanitizer59 mL in 1 BOTTLEGEL591
78403-001-07Hand Sanitizer60 mL in 1 BOTTLEGEL601
78403-001-08Hand Sanitizer80 mL in 1 BOTTLEGEL801
78403-001-09Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78403-001-10Hand Sanitizer200 mL in 1 BOTTLEGEL2001
78403-001-11Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78403-001-12Hand Sanitizer300 mL in 1 BOTTLEGEL3001
78403-001-13Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78403-001-14Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
78403-001-15Hand Sanitizer3780 mL in 1 BOTTLEGEL37801
78403-001-16Hand Sanitizer5000 mL in 1 BOTTLEGEL50001
78403-001-17Hand Sanitizer18900 mL in 1 BOTTLEGEL189001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78403-001HAND SANITIZER GEL [GUANGZHOU CANGTY BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 17 package rows20200527_a686f01c-4346-6371-e053-2995a90a2c3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa686f01c-4346-6371-e053-2995a90a2c3b1
1305100ethanol 0.75 ML/ML Topical GelSCDa686f01c-4346-6371-e053-2995a90a2c3b1
1305100ethanol 75 % Topical GelSYa686f01c-4346-6371-e053-2995a90a2c3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78403-001-01784030001015 mL in 1 BOTTLE (78403-001-01) 5 ml2020-05-160000-00-00NoNoCurrent