Antibacterial Instant Hand Sanitizer

Product NDC
55467-015
Requested package NDC
55467-015-04
11-digit product format
554670015
Labeler code
55467
Product ID
55467-015_a83e3706-12df-249b-e053-2995a90a095c
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-17
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 packagepackage55467-01555467-015-04IInactivated 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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55467-015-01Antibacterial Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1001
55467-015-02Antibacterial Instant Hand Sanitizer30 mL in 1 BOTTLEGEL301
55467-015-03Antibacterial Instant Hand Sanitizer60 mL in 1 BOTTLEGEL601
55467-015-04Antibacterial Instant Hand Sanitizer120 mL in 1 BOTTLEGEL1201
55467-015-05Antibacterial Instant Hand Sanitizer250 mL in 1 BOTTLEGEL2501
55467-015-06Antibacterial Instant Hand Sanitizer300 mL in 1 BOTTLEGEL3001
55467-015-07Antibacterial Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5001
55467-015-08Antibacterial Instant Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
55467-015-09Antibacterial Instant Hand Sanitizer3780 mL in 1 PAILGEL37801
55467-015-10Antibacterial Instant Hand Sanitizer1000000 mL in 1 PAILGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55467-015ANTIBACTERIAL INSTANT HAND SANITIZER (HAND SANITIZER) GEL [INTENTLY (GUANGZHOU) BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 10 package rows20200617_a83e3706-12de-249b-e053-2995a90a095c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa83e3706-12de-249b-e053-2995a90a095c1
1305100ethanol 0.75 ML/ML Topical GelSCDa83e3706-12de-249b-e053-2995a90a095c1
1305100ethanol 75 % Topical GelSYa83e3706-12de-249b-e053-2995a90a095c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55467-015-0455467001504120 mL in 1 BOTTLE (55467-015-04) 120 ml2020-06-170000-00-00NoNoCurrent