FDA.reportPublic FDA data

Neat Hand Sanitizer

Product NDC
78824-615
Requested package NDC
78824-615-02
11-digit product format
788240615
Labeler code
78824
Product ID
78824-615_b7ca8842-16e1-9289-e053-2a95a90aa38a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Artesanales P.R. LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 mL/100mL
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 packagepackage78824-61578824-615-02IInactivated by FDA2026-10-05

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 packagepackage78824-61578824-615-02IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78824-61578824-615-02IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
78824-615-012025-07-29C16284748780-1f386c64a-09d9-0266-e053-dadaa90a7c1aHand Sanitizer Neat 80% Ethyl
78824-615-022025-07-29C16284748780-1f386c64a-09d9-0266-e053-dadaa90a7c1aHand Sanitizer Neat 80% Ethyl
78824-615-032025-07-29C16284748780-1f386c64a-09d9-0266-e053-dadaa90a7c1aHand Sanitizer Neat 80% Ethyl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78824-615-01Neat Hand Sanitizer3790 mL in 1 BOTTLELIQUID37905
78824-615-02Neat Hand Sanitizer237 mL in 1 BOTTLELIQUID2375
78824-615-03Neat Hand Sanitizer476 mL in 1 BOTTLELIQUID4765

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78824-615NEAT HAND SANITIZER (ALCOHOL) LIQUID [ARTESANALES P.R. LLC]5Legacy NDC, 3 package rows20240427_b7ca85ee-30e3-6ddc-e053-2a95a90a2b7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSNb7ca85ee-30e3-6ddc-e053-2a95a90a2b7c5
1041498ethanol 0.8 ML/ML Topical GelSCDb7ca85ee-30e3-6ddc-e053-2a95a90a2b7c5
1041498ethanol 80 % Topical GelSYb7ca85ee-30e3-6ddc-e053-2a95a90a2b7c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78824-615-0278824061502237 mL in 1 BOTTLE (78824-615-02) 237 ml2020-03-300000-00-00NoNoCurrent