FDA.reportPublic FDA data

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution

Product NDC
64521-5678
Requested package NDC
64521-5678-2
11-digit product format
645215678
Labeler code
64521
Product ID
64521-5678_a33fd467-2fbd-7eee-e053-2995a90ae098
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sarkli-Repechage, Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-31
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#

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 packagepackage64521-567864521-5678-2IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64521-5678-12022-01-28C16284748780-1d6a99b39-6ed4-a426-e053-dadaa90af4c2Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
64521-5678-22022-01-28C16284748780-1d6a99b39-6ed4-a426-e053-dadaa90af4c2Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
64521-5678-42022-01-28C16284748780-1d6a99b39-6ed4-a426-e053-dadaa90af4c2Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
64521-5678-82022-01-28C16284748780-1d6a99b39-6ed4-a426-e053-dadaa90af4c2Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64521-5678-1Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution473 mL in 1 BOTTLESOLUTION4734
64521-5678-2Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution59 mL in 1 BOTTLE, SPRAYSOLUTION594
64521-5678-4Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution118 mL in 1 BOTTLE, SPRAYSOLUTION1184
64521-5678-8Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution236 mL in 1 BOTTLE, SPRAYSOLUTION2364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64521-5678ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION (ALCOHOL) SOLUTION [SARKLI-REPECHAGE, LTD.]4Legacy NDC, 4 package rows20200415_a19c0b93-ae48-7b62-e053-2a95a90a701c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNa19c0b93-ae48-7b62-e053-2a95a90a701c4
1039339ethanol 0.8 ML/ML Topical SolutionSCDa19c0b93-ae48-7b62-e053-2a95a90a701c4
1039339ethanol 80 % Topical SolutionSYa19c0b93-ae48-7b62-e053-2a95a90a701c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64521-5678-26452156780259 mL in 1 BOTTLE, SPRAY (64521-5678-2) 59 ml2020-03-310000-00-00NoNoCurrent