SUDS Hand Sanitizer

Product NDC
63830-457
Requested package NDC
63830-457-18
11-digit product format
638300457
Labeler code
63830
Product ID
63830-457_f210a3ee-1ad5-4832-ae44-b74d14a26a07
Type
HUMAN OTC DRUG
Nonproprietary name
BENZEALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pro Chem, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-08-12
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage63830-45763830-457-18DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63830-45763830-457-18DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63830-45763830-457-18UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63830-457SUDS HAND SANITIZER (BENZEALKONIUM CHLORIDE) LIQUID [PRO CHEM, INC.]2Legacy NDC20250112_255a7864-e20d-43b1-b0bc-2362c984f359.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63830-457-186383004571850 mL in 1 BOTTLE, PLASTIC (63830-457-18) 50 ml2019-08-120000-00-00NoNoCurrent