FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
73549-002
Requested package NDC
73549-002-12
11-digit product format
735490002
Labeler code
73549
Product ID
73549-002_a4b7b236-2223-810b-e053-2a95a90ac08e
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Fortress Expert Co., Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-03
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 packagepackage73549-00273549-002-12IInactivated 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#

NDC, Related label table
NDCRelated label
73549-002-01HAND SANITIZER
73549-002-02HAND SANITIZER
73549-002-03HAND SANITIZER
73549-002-04HAND SANITIZER
73549-002-05HAND SANITIZER
73549-002-06HAND SANITIZER
73549-002-07HAND SANITIZER
73549-002-08HAND SANITIZER
73549-002-09HAND SANITIZER
73549-002-10HAND SANITIZER
73549-002-11HAND SANITIZER
73549-002-12HAND SANITIZER
73549-002-13HAND SANITIZER
73549-002-14HAND SANITIZER
73549-002-15HAND SANITIZER
73549-002-16HAND SANITIZER
73549-002-17HAND SANITIZER
73549-002-18HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-002-01Hand Sanitizer15 mL in 1 BOTTLEGEL151
73549-002-02Hand Sanitizer30 mL in 1 BOTTLEGEL301
73549-002-03Hand Sanitizer50 mL in 1 BOTTLEGEL501
73549-002-04Hand Sanitizer59 mL in 1 BOTTLEGEL591
73549-002-05Hand Sanitizer65 mL in 1 BOTTLEGEL651
73549-002-06Hand Sanitizer100 mL in 1 BOTTLEGEL1001
73549-002-07Hand Sanitizer120 mL in 1 BOTTLEGEL1201
73549-002-08Hand Sanitizer150 mL in 1 BOTTLEGEL1501
73549-002-09Hand Sanitizer236 mL in 1 BOTTLEGEL2361
73549-002-10Hand Sanitizer250 mL in 1 BOTTLEGEL2501
73549-002-11Hand Sanitizer300 mL in 1 BOTTLEGEL3001
73549-002-12Hand Sanitizer330 mL in 1 BOTTLEGEL3301
73549-002-13Hand Sanitizer480 mL in 1 BOTTLEGEL4801
73549-002-14Hand Sanitizer500 mL in 1 BOTTLEGEL5001
73549-002-15Hand Sanitizer944 mL in 1 BOTTLEGEL9441
73549-002-16Hand Sanitizer950 mL in 1 BOTTLEGEL9501
73549-002-17Hand Sanitizer1800 mL in 1 BOTTLEGEL18001
73549-002-18Hand Sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-002HAND SANITIZER GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 18 package rows20200509_a4bbba5e-c991-9481-e053-2995a90acefc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2367754ethanol 75.1 % Topical GelPSNa4bbba5e-c991-9481-e053-2995a90acefc1
2367754ethanol 0.751 ML/ML Topical GelSCDa4bbba5e-c991-9481-e053-2995a90acefc1
2367754ethanol 75.1 % Topical GelSYa4bbba5e-c991-9481-e053-2995a90acefc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73549-002-1273549000212330 mL in 1 BOTTLE (73549-002-12) 330 ml2020-05-030000-00-00NoNoCurrent