Instant Hand Sanitizer

Product NDC
61010-2111
Requested package NDC
61010-2111-7
11-digit product format
610102111
Labeler code
61010
Product ID
61010-2111_2e61d674-cb19-44fa-a13f-a2f0fdb4ad7c
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
540 g/L
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 packagepackage61010-211161010-2111-7IInactivated by FDA2026-10-12

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 · 20 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-2111-1Instant Hand Sanitizer0.118 L in 1 BOTTLEGEL0.1182
61010-2111-4Instant Hand Sanitizer0.473 L in 1 BOTTLEGEL0.4732
61010-2111-7Instant Hand Sanitizer1.9 L in 1 BOTTLEGEL1.92
61010-2111-9A.B.H.C. Instant Hand Sanitizer Citrus Scent1041 L in 1 CONTAINERGEL10411

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90MA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2
alcoholACTIVE MOIETY3K9958V90MA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2
carbomer interpolymer type a (55000 mpa.s)INACTIVE INGREDIENT59TL3WG5COA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2
trolamineINACTIVE INGREDIENT9O3K93S3TKA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2
AlcoholACTIVE INGREDIENT3K9958V90MA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
alcoholACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
AlcoholACTIVE MOIETY3K9958V90MA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
alcoholACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
AloeINACTIVE INGREDIENTV5VD430YW9A.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
carbomer interpolymer type a (55000 mpa.s)INACTIVE INGREDIENT59TL3WG5COINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RA.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-2111INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200811_691462b7-d118-4018-8985-5e32f38146d9.zip
61010-2111A.B.H.C. INSTANT HAND SANITIZER CITRUS SCENT (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.]1Legacy NDC, 1 package rows20100501_20e8fb92-7c86-4c88-b0ad-a78c03c60c89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616762ethanol 66.5 % Topical GelPSN20e8fb92-7c86-4c88-b0ad-a78c03c60c891
616762ethanol 0.665 ML/ML Topical GelSCD20e8fb92-7c86-4c88-b0ad-a78c03c60c891
616762ethanol 66.5 % Topical GelSY20e8fb92-7c86-4c88-b0ad-a78c03c60c891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-2111-7610102111071.9 L in 1 BOTTLE (61010-2111-7) 1.9 l2012-05-100000-00-00NoNoCurrent