FDA.reportPublic FDA data

INSTANT HAND SANITIZER

Product NDC
77976-001
Requested package NDC
77976-001-10
11-digit product format
779760001
Labeler code
77976
Product ID
77976-001_aa13cecd-965a-8059-e053-2995a90a7ff8
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Whealth Lohmann Centralin (GZ) Co., Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-28
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
343 mL/520mL
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 packagepackage77976-00177976-001-10IInactivated 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, Indexing SPL, Related label table
NDCIndexing SPLRelated label
77976-001-05d6a99b39-5cbf-a426-e053-dadaa90af4c2a6b13387-fb36-658d-e053-2a95a90a5af5
77976-001-10d6a99b39-c4a7-a426-e053-dadaa90af4c2a6b436bd-5721-6bfc-e053-2995a90a44c7
77976-001-92d6a99b39-5cc2-a426-e053-dadaa90af4c2a6b29fc2-3e44-2a0e-e053-2995a90adb30
77976-001-95d6a99b39-76cc-a426-e053-dadaa90af4c2a6b3c882-3f3c-558d-e053-2995a90a0b86

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77976-001-05INSTANT HAND SANITIZER50 mL in 1 BOTTLE, PUMPGEL502
77976-001-10INSTANT HAND SANITIZER1000 mL in 1 BOTTLE, PUMPGEL10002
77976-001-92INSTANT HAND SANITIZER250 mL in 1 BOTTLE, PUMPGEL2502
77976-001-95INSTANT HAND SANITIZER520 mL in 1 BOTTLE, PUMPGEL5202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77976-001INSTANT HAND SANITIZER (HAND SANITIZER) GEL [WHEALTH LOHMANN CENTRALIN (GZ) CO., LTD.]2Legacy NDC, 1 package rows20200711_a6b29fc2-3e44-2a0e-e053-2995a90adb30.zip
77976-001INSTANT HAND SANITIZER (HAND SANITIZER) GEL [WHEALTH LOHMANN CENTRALIN (GZ) CO., LTD.]2Legacy NDC, 1 package rows20200711_a6b436bd-5721-6bfc-e053-2995a90a44c7.zip
77976-001INSTANT HAND SANITIZER (HAND SANITIZER) GEL [WHEALTH LOHMANN CENTRALIN (GZ) CO., LTD]2Legacy NDC, 1 package rows20200711_a6b13387-fb36-658d-e053-2a95a90a5af5.zip
77976-001INSTANT HAND SANITIZER (HAND SANITIZER) GEL [WHEALTH LOHMANN CENTRALIN (GZ) CO., LTD]2Legacy NDC, 1 package rows20200711_a6b3c882-3f3c-558d-e053-2995a90a0b86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039811ethanol 66 % Topical GelPSNa6b13387-fb36-658d-e053-2a95a90a5af52
1039811ethanol 66 % Topical GelPSNa6b29fc2-3e44-2a0e-e053-2995a90adb302
1039811ethanol 66 % Topical GelPSNa6b3c882-3f3c-558d-e053-2995a90a0b862
1039811ethanol 66 % Topical GelPSNa6b436bd-5721-6bfc-e053-2995a90a44c72
1039811ethanol 0.66 ML/ML Topical GelSCDa6b13387-fb36-658d-e053-2a95a90a5af52
1039811ethanol 0.66 ML/ML Topical GelSCDa6b29fc2-3e44-2a0e-e053-2995a90adb302
1039811ethanol 0.66 ML/ML Topical GelSCDa6b3c882-3f3c-558d-e053-2995a90a0b862
1039811ethanol 0.66 ML/ML Topical GelSCDa6b436bd-5721-6bfc-e053-2995a90a44c72
1039811ethanol 66 % Topical GelSYa6b13387-fb36-658d-e053-2a95a90a5af52
1039811ethanol 66 % Topical GelSYa6b29fc2-3e44-2a0e-e053-2995a90adb302
1039811ethanol 66 % Topical GelSYa6b3c882-3f3c-558d-e053-2995a90a0b862
1039811ethanol 66 % Topical GelSYa6b436bd-5721-6bfc-e053-2995a90a44c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77976-001-10779760001101000 mL in 1 BOTTLE, PUMP (77976-001-10) 1000 ml2020-05-280000-00-00NoNoCurrent