FDA.reportPublic FDA data

HYGIENIGEL

Product NDC
78619-200
Requested package NDC
78619-200-08
11-digit product format
786190200
Labeler code
78619
Product ID
78619-200_bc911eb3-52d8-c42d-e053-2995a90a02b4
Type
HUMAN OTC DRUG
Nonproprietary name
Hand sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
HAIKOWER S.r.l.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-25
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 packagepackage78619-20078619-200-08IInactivated 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 · 16 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…

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
78619-200-02Hygienigel Gel - 70%
78619-200-03Hygienigel Gel - 70%
78619-200-04Hygienigel Gel - 70%
78619-200-05Hygienigel Gel - 70%
78619-200-06Hygienigel Gel - 70%
78619-200-07Hygienigel Gel - 70%
78619-200-08Hygienigel Gel - 70%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78619-200-02HYGIENIGEL30 mL in 1 POUCHGEL303
78619-200-03HYGIENIGEL70 mL in 1 POUCHGEL703
78619-200-04HYGIENIGEL100 mL in 1 BOTTLE, PLASTICGEL1003
78619-200-05HYGIENIGEL500 mL in 1 BOTTLE, PLASTICGEL5003
78619-200-06HYGIENIGEL1000 mL in 1 BOTTLE, PLASTICGEL10003
78619-200-07HYGIENIGEL5000 mL in 1 CANGEL50003
78619-200-08HYGIENIGEL2 mL in 1 POUCHGEL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78619-200HYGIENIGEL (HAND SANITIZER) GEL [HAIKOWER S.R.L.]3Legacy NDC, 7 package rows20210303_bc32a828-3fd4-4494-e053-2a95a90a596a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNbc32a828-3fd4-4494-e053-2a95a90a596a3
581662ethanol 0.7 ML/ML Topical GelSCDbc32a828-3fd4-4494-e053-2a95a90a596a3
581662ethanol 70 % Topical GelSYbc32a828-3fd4-4494-e053-2a95a90a596a3
581662ethyl alcohol 70 % Topical GelSYbc32a828-3fd4-4494-e053-2a95a90a596a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78619-200-08786190200082 mL in 1 POUCH (78619-200-08) 2 ml2021-02-250000-00-00NoNoCurrent