FDA.reportPublic FDA data

Aplicare Antiseptic Hand Rinse

Product NDC
52380-0540
11-digit product format
523800540
Labeler code
52380
Product ID
52380-0540_efe327ce-23aa-60a6-e053-2a95a90abf12
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
Aplicare Products, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-08-01
Marketing end
2025-07-31
Substance
ALCOHOL
Active strength
1 mL/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52380-0540DDiscontinued by firm2026-10-05
excluded packagepackage52380-054052380-0540-1DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52380-0540-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52380-0540-1f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90MAPLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE, INC.]6
AlcoholACTIVE MOIETY3K9958V90MAPLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE, INC.]6
DiisopropanolamineINACTIVE INGREDIENT0W44HYL8T5APLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE, INC.]6
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDAPLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE, INC.]6
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MAPLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE, INC.]6
WaterINACTIVE INGREDIENT059QF0KO0RAPLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0540APLICARE ANTISEPTIC HAND RINSE (ETHANOL) GEL [APLICARE PRODUCTS, LLC]11Legacy NDC20221217_fcf08e5a-7212-4b06-a93c-34425e7a5b7e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-0540-1523800540011.5 mL in 1 PACKET (52380-0540-1) 1.5 ml2018-02-142021-07-01NoNoCurrent