FDA.reportPublic FDA data

Guard Hand Sanitizer

Product NDC
63148-519
Requested package NDC
63148-519-08
11-digit product format
631480519
Labeler code
63148
Product ID
63148-519_4c03db90-9cbb-4c45-87ec-ceecbb818357
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Apollo Health and Beauty Care Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-09
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
700 mg/mL
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 packagepackage63148-51963148-519-08DDiscontinued by firm2026-08-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-519GUARD HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE INC.]2Legacy NDC20250107_c4f8bcd5-0593-4e37-bd91-9bf0dedbc676.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63148-519-0863148051908236 mL in 1 BOTTLE, PLASTIC (63148-519-08) 236 ml2020-06-090000-00-00NoNoCurrent