FDA.reportPublic FDA data

Instant Hand Sanitizer

Product NDC
78294-001
Requested package NDC
78294-001-04
11-digit product format
782940001
Labeler code
78294
Product ID
78294-001_a6379805-cda3-13ae-e053-2995a90a7d30
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
LOTUS ARTS CRAFTS LIMITED
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-22
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78294-00178294-001-04IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78294-001-012022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer
78294-001-022022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer
78294-001-032022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer
78294-001-042022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer
78294-001-052022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer
78294-001-062022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer
78294-001-072022-01-28C16284748780-1d6a99b39-8cfe-a426-e053-dadaa90af4c2hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78294-001-01Instant Hand Sanitizer30 mL in 1 BOTTLEGEL301
78294-001-02Instant Hand Sanitizer60 mL in 1 BOTTLEGEL601
78294-001-03Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78294-001-04Instant Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78294-001-05Instant Hand Sanitizer300 mL in 1 BOTTLEGEL3001
78294-001-06Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78294-001-07Instant Hand Sanitizer1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78294-001INSTANT HAND SANITIZER (ALCOHOL) GEL [LOTUS ARTS CRAFTS LIMITED]1Legacy NDC, 7 package rows20200522_a6378a16-f5ff-55a9-e053-2995a90a7377.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa6378a16-f5ff-55a9-e053-2995a90a73771
1305100ethanol 0.75 ML/ML Topical GelSCDa6378a16-f5ff-55a9-e053-2995a90a73771
1305100ethanol 75 % Topical GelSYa6378a16-f5ff-55a9-e053-2995a90a73771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78294-001-0478294000104250 mL in 1 BOTTLE (78294-001-04) 250 ml2020-05-220000-00-00NoNoCurrent