FDA.reportPublic FDA data

GELRITE

Product NDC
61924-106
Requested package NDC
61924-106-16
11-digit product format
619240106
Labeler code
61924
Product ID
61924-106_d57d3812-9482-56a6-e053-2a95a90aaa82
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
DERMARITE INDUSTRIES, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-04-25
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage61924-10661924-106-16IInactivated 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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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, Related label table
NDCEffectiveRelated label
61924-106-042026-01-29GELRITE
61924-106-162026-01-29GELRITE
61924-106-272026-01-29GELRITE
61924-106-342026-01-29GELRITE
61924-106-042024-12-06GELRITE
61924-106-162024-12-06GELRITE
61924-106-272024-12-06GELRITE
61924-106-342024-12-06GELRITE
61924-106-042024-01-30GELRITE
61924-106-162024-01-30GELRITE
61924-106-272024-01-30GELRITE
61924-106-342024-01-30GELRITE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-106-04GELRITE118 mL in 1 BOTTLE, DISPENSINGGEL1189
61924-106-16GELRITE473 mL in 1 BOTTLE, PUMPGEL4739
61924-106-27GELRITE800 mL in 1 BAGGEL8009
61924-106-34GELRITE1000 mL in 1 BAGGEL10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-106-04ML - Milliliter61924-106716b6d40-3f1d-454a-b610-6f3d16b084fd12017-11-06
61924-106-16ML - Milliliter61924-10673061636-bee7-4e73-9296-483ad0306cdf12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-106GELRITE (HAND SANITIZER) GEL [DERMARITE INDUSTRIES, LLC]9Legacy NDC, 4 package rows20241208_4180193e-9d34-2ecf-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSN4180193e-9d34-2ecf-e054-00144ff88e889
902574ethanol 0.65 ML/ML Topical GelSCD4180193e-9d34-2ecf-e054-00144ff88e889
902574ethyl alcohol 65 % Topical GelSY4180193e-9d34-2ecf-e054-00144ff88e889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-106-1661924010616473 mL in 1 BOTTLE, PUMP (61924-106-16) 473 ml2006-04-250000-00-00NoNoCurrent