FDA.reportPublic FDA data

AFCO 5515 Hand Sanitizer

Product NDC
68776-1007
Requested package NDC
68776-1007-4
11-digit product format
687761007
Labeler code
68776
Product ID
68776-1007_c9726b7d-acc5-4c5b-a69e-3a6642ba1414
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
LOTION
Route
TOPICAL
Labeler
Alex C. Fergusson, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-16
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
1 g/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 packagepackage68776-100768776-1007-4DDiscontinued 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 · 1 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 packagepackage68776-100768776-1007-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
68776-1007AFCO 5515 HAND SANITIZER (ISOPROPYL ALCOHOL) LOTION [ACUITY SPECIALTY PRODUCTS, INC DBA AFCO US]4Legacy NDC20241220_5e6d7456-c4e9-4de7-a6f6-d23559c8e130.zip
68776-1007AFCO 5515 HAND SANITIZER (ISOPROPYL ALCOHOL) LOTION [ACUITY SPECIALTY PRODUCTS, INC DBA AFCO US]4Legacy NDC20241220_548be1b7-1c45-43a0-bbd9-6d03821a0dd2.zip
68776-1007AFCO 5515 HAND SANITIZER (ISOPROPYL ALCOHOL) LOTION [ACUITY SPECIALTY PRODUCTS, INC DBA AFCO US]4Legacy NDC20241220_bd7d9810-9b35-4d94-ab6c-4a35926da70d.zip
68776-1007AFCO 5515 HAND SANITIZER (ISOPROPYL ALCOHOL) LOTION [ACUITY SPECIALTY PRODUCTS, INC DBA AFCO US]3Legacy NDC20241220_dfebdd54-c04a-4684-9d2a-2fc76f5c7d47.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68776-1007-4687761007046 CARTRIDGE in 1 CASE (68776-1007-4) > 1000 mL in 1 CARTRIDGE6 cartridge2020-03-160000-00-00NoNoCurrent