Smart Care Advanced Hand Sanitizer

Product NDC
54860-346
Requested package NDC
54860-346-01
11-digit product format
548600346
Labeler code
54860
Product ID
54860-346_6a9c1fd2-cf06-4274-b9cb-587dcb9b2ac3
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Shenzhen Lantern Science Co., ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-07
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage54860-34654860-346-01IInactivated by FDA2026-09-14

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 · 15 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…

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
54860-346-012023-01-30C16284748780-1f386c64a-0ea5-0266-e053-dadaa90a7c1aSmart Care ®  ADVANCED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54860-346-01Smart Care Advanced Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54860-346SMART CARE ADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [SHENZHEN LANTERN SCIENCE CO., LTD.]2Legacy NDC, 1 package rows20210127_7e5d6aed-a8ee-42a0-99dc-79eb40c47a06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN7e5d6aed-a8ee-42a0-99dc-79eb40c47a062
581662ethanol 0.7 ML/ML Topical GelSCD7e5d6aed-a8ee-42a0-99dc-79eb40c47a062
581662ethanol 70 % Topical GelSY7e5d6aed-a8ee-42a0-99dc-79eb40c47a062
581662ethyl alcohol 70 % Topical GelSY7e5d6aed-a8ee-42a0-99dc-79eb40c47a062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54860-346-0154860034601500 mL in 1 BOTTLE (54860-346-01) 500 ml2021-01-070000-00-00NoNoCurrent