FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
25113-444
Requested package NDC
25113-444-16
11-digit product format
251130444
Labeler code
25113
Product ID
25113-444_db072baa-03b2-4847-a996-759e482d36ca
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Dodge
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-03-18
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
665 mg/L
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage25113-44425113-444-16IInactivated 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25113-444-162024-12-27C16284748780-11030e365-4b40-111a-e063-dadaa90a10e225113-444-16, Hand Sanitizer
25113-444-162024-01-30C16284748780-11030e365-4b40-111a-e063-dadaa90a10e225113-444-16, Hand Sanitizer
25113-444-152021-01-29C16284748780-1ba0f9c33-215c-a910-e053-dadaa90a0b850d84f448-f439-4e81-bc73-d50d48e65dac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25113-444-15Instant Hand Sanitizer0.0443 L in 1 BOTTLEGEL0.04432
25113-444-16Instant Hand Sanitizer0.059 L in 1 BOTTLEGEL0.0592

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]1
alcoholACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]1
aloeINACTIVE INGREDIENTV5VD430YW9INSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]1
trolamineINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]1
waterINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25113-444INSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]2Legacy NDC, 1 package rows20241228_c5e44a46-c198-4ecd-8624-560146bb5ea5.zip
25113-444INSTANT HAND SANITIZER (ALCOHOL) GEL [DODGE]2Legacy NDC, 1 package rows20191231_0d84f448-f439-4e81-bc73-d50d48e65dac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616762ethanol 66.5 % Topical GelPSN0d84f448-f439-4e81-bc73-d50d48e65dac2
616762ethanol 66.5 % Topical GelPSNc5e44a46-c198-4ecd-8624-560146bb5ea52
616762ethanol 0.665 ML/ML Topical GelSCD0d84f448-f439-4e81-bc73-d50d48e65dac2
616762ethanol 0.665 ML/ML Topical GelSCDc5e44a46-c198-4ecd-8624-560146bb5ea52
616762ethanol 66.5 % Topical GelSY0d84f448-f439-4e81-bc73-d50d48e65dac2
616762ethanol 66.5 % Topical GelSYc5e44a46-c198-4ecd-8624-560146bb5ea52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
25113-444-1625113044416.059 L in 1 BOTTLE (25113-444-16) 2022-03-180000-00-00NoNoCurrent