Rinse Free Hand Sanitizing Gel

Product NDC
78963-005
Requested package NDC
78963-005-16
11-digit product format
789630005
Labeler code
78963
Product ID
78963-005_aba09b5d-779a-e5d6-e053-2995a90a80b6
Type
HUMAN OTC DRUG
Nonproprietary name
Rinse Free Hand Sanitizing Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Qianxiancao 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
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 packagepackage78963-00578963-005-16IInactivated 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 · 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78963-005-01Rinse Free Hand Sanitizing Gel30 mL in 1 BOTTLEGEL302
78963-005-02Rinse Free Hand Sanitizing Gel50 mL in 1 BOTTLEGEL502
78963-005-03Rinse Free Hand Sanitizing Gel60 mL in 1 BOTTLEGEL602
78963-005-04Rinse Free Hand Sanitizing Gel80 mL in 1 BOTTLEGEL802
78963-005-05Rinse Free Hand Sanitizing Gel100 mL in 1 BOTTLEGEL1002
78963-005-06Rinse Free Hand Sanitizing Gel120 mL in 1 BOTTLEGEL1202
78963-005-07Rinse Free Hand Sanitizing Gel200 mL in 1 BOTTLEGEL2002
78963-005-08Rinse Free Hand Sanitizing Gel250 mL in 1 BOTTLEGEL2502
78963-005-09Rinse Free Hand Sanitizing Gel300 mL in 1 BOTTLEGEL3002
78963-005-10Rinse Free Hand Sanitizing Gel500 mL in 1 BOTTLEGEL5002
78963-005-11Rinse Free Hand Sanitizing Gel1000 mL in 1 BOTTLEGEL10002
78963-005-12Rinse Free Hand Sanitizing Gel1200 mL in 1 BOTTLEGEL12002
78963-005-13Rinse Free Hand Sanitizing Gel4000 mL in 1 BOTTLEGEL40002
78963-005-14Rinse Free Hand Sanitizing Gel5000 mL in 1 BOTTLEGEL50002
78963-005-15Rinse Free Hand Sanitizing Gel10000 mL in 1 BOTTLEGEL100002
78963-005-16Rinse Free Hand Sanitizing Gel20000 mL in 1 BOTTLEGEL200002
78963-005-17Rinse Free Hand Sanitizing Gel50000 mL in 1 BOTTLEGEL500002
78963-005-18Rinse Free Hand Sanitizing Gel100000 mL in 1 BOTTLEGEL1000002
78963-005-19Rinse Free Hand Sanitizing Gel150000 mL in 1 BOTTLEGEL1500002
78963-005-20Rinse Free Hand Sanitizing Gel1000000 mL in 1 BOTTLEGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78963-005RINSE FREE HAND SANITIZING GEL GEL [GUANGZHOU QIANXIANCAO COSMETICS CO.,LTD.]2Legacy NDC, 20 package rows20200730_a7dfdefe-05ca-d2b8-e053-2a95a90ad4ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa7dfdefe-05ca-d2b8-e053-2a95a90ad4ef2
1305100ethanol 0.75 ML/ML Topical GelSCDa7dfdefe-05ca-d2b8-e053-2a95a90ad4ef2
1305100ethanol 75 % Topical GelSYa7dfdefe-05ca-d2b8-e053-2a95a90ad4ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78963-005-167896300051620000 mL in 1 BOTTLE (78963-005-16) 20000 ml2020-03-300000-00-00NoNoCurrent