SHEA BUTTER SCENTED HAND SANITIZER

Product NDC
80684-122
11-digit product format
806840122
Labeler code
80684
Product ID
80684-122_2ef27711-9312-b8c7-e063-6294a90a9bf1
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-15
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SHEA BUTTER SCENTED HAND SANITIZER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui582753

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80684-122-002025-02-25C16284748780-12cef2736-8d43-d83d-e063-dadaa90ab31fSHEA BUTTER SCENTED HAND SANITIZER
80684-122-002025-01-30C16284748780-12cef2736-8d43-d83d-e063-dadaa90ab31fSHEA BUTTER SCENTED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-122-00SHEA BUTTER SCENTED HAND SANITIZER89 mL in 1 BOTTLELIQUID892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-122SHEA BUTTER SCENTED HAND SANITIZER (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20250227_669451fa-7557-4ef5-a668-fe4fea1f0c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN669451fa-7557-4ef5-a668-fe4fea1f0c9b2
582753ethanol 0.7 ML/ML Topical SolutionSCD669451fa-7557-4ef5-a668-fe4fea1f0c9b2
582753ethanol 70 % Topical SolutionSY669451fa-7557-4ef5-a668-fe4fea1f0c9b2
582753ethyl alcohol 70 % Topical SolutionSY669451fa-7557-4ef5-a668-fe4fea1f0c9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-122-008068401220089 mL in 1 BOTTLE (80684-122-00) 89 ml2023-08-15NoNoCurrent