(Fruli) Hand Antiseptic Rinse Free Gel

Product NDC
77442-003
Requested package NDC
77442-003-03
11-digit product format
774420003
Labeler code
77442
Product ID
77442-003_a7dd7c69-3adc-8a73-e053-2a95a90a663d
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Shandong Zhuojian Medical Technology Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-01
Marketing end
0000-00-00
Substance
ALCOHOL; PROPYL ALCOHOL
Active strength
66 mL/100mL; mg/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 packagepackage77442-00377442-003-03IInactivated 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 · 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77442-003-01(Fruli) Hand Antiseptic Rinse Free Gel60 mL in 1 BOTTLE, DROPPERGEL602
77442-003-02(Fruli) Hand Antiseptic Rinse Free Gel100 mL in 1 BOTTLE, DROPPERGEL1002
77442-003-03(Fruli) Hand Antiseptic Rinse Free Gel250 mL in 1 BOTTLE, DROPPERGEL2502
77442-003-04(Fruli) Hand Antiseptic Rinse Free Gel500 mL in 1 BOTTLE, DROPPERGEL5002
77442-003-05(Fruli) Hand Antiseptic Rinse Free Gel1000 mL in 1 BOTTLE, DROPPERGEL10002
77442-003-06(Fruli) Hand Antiseptic Rinse Free Gel5000 mL in 1 BOTTLE, DROPPERGEL50002
77442-003-07(Fruli) Hand Antiseptic Rinse Free Gel3 mL in 1 BAGGEL32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77442-003(FRULI) HAND ANTISEPTIC RINSE FREE GEL (ALCOHOL) GEL [SHANDONG ZHUOJIAN MEDICAL TECHNOLOGY CO., LTD.]2Legacy NDC, 7 package rows20200613_a548ab68-71c8-709a-e053-2995a90af1f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77442-003-0377442000303250 mL in 1 BOTTLE, DROPPER (77442-003-03) 250 ml2020-05-010000-00-00NoNoCurrent