Aroma Guardian

Product NDC
42477-2022
Requested package NDC
42477-2022-1
11-digit product format
424772022
Labeler code
42477
Product ID
42477-2022_a36e15e6-8ca1-ffc4-e053-2995a90aecf0
Type
HUMAN OTC DRUG
Nonproprietary name
Anti Bacterial Instant Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Opal Cosmetics (Huizhou) Limited
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-17
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
71 mL/95mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42477-2022-12022-01-28C16284748780-1d6a99b39-3ada-a426-e053-dadaa90af4c2Opal, Hand Sanitizer, Gel, 75% Ethyl alcohol, 95mL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42477-2022AROMA GUARDIAN (ANTI BACTERIAL INSTANT HAND SANITIZER) GEL [OPAL COSMETICS (HUIZHOU) LIMITED]1Legacy NDC20200417_a36e15e6-8ca0-ffc4-e053-2995a90aecf0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42477-2022-14247720220195 mL in 1 BOTTLE, PLASTIC (42477-2022-1) 95 ml2020-04-170000-00-00NoNoCurrent