FDA.reportPublic FDA data

Bac-Off

Product NDC
76315-1052
Requested package NDC
76315-1052-1
11-digit product format
763151052
Labeler code
76315
Product ID
76315-1052_d5fbd8c2-54d0-419d-a4ef-2e818242114b
Type
HUMAN OTC DRUG
Nonproprietary name
Foaming Hand Sanitizer
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
DeVere Company, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-08-15
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
100 g/100L
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 packagepackage76315-105276315-1052-1DDiscontinued by firm2026-10-12

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 · 6 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 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
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…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76315-1052-12022-08-15C16284748780-19d75b9d0-9ebf-f424-e053-dadaa90a57ce7d6a08ef-77d7-4b8c-88dd-2a2137bb9e1a
76315-1052-12020-01-31C16284748780-19d75b9d0-9ebf-f424-e053-dadaa90a57ce7d6a08ef-77d7-4b8c-88dd-2a2137bb9e1a

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7BAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]3
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YBAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]3
C12-15 PARETH-10INACTIVE INGREDIENTZ0QJT9586TBAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76315-1052BAC-OFF (FOAMING HAND SANITIZER) AEROSOL, FOAM [DEVERE COMPANY, INC.]9Legacy NDC20250214_7d6a08ef-77d7-4b8c-88dd-2a2137bb9e1a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76315-1052-1763151052013.8 L in 1 JUG (76315-1052-1) 3.8 l2022-08-150000-00-00NoNoCurrent