b pure Hand Sanitizer Shea Butter Scented

Product NDC
80684-116
11-digit product format
806840116
Labeler code
80684
Product ID
80684-116_1bb893c5-862f-d304-e063-6394a90ad206
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
2024-08-25
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
b pure Hand Sanitizer Shea Butter Scented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-116-00b pure Hand Sanitizer Shea Butter Scented1 in 1 BOXLIQUID11
80684-116-00b pure Hand Sanitizer Shea Butter Scented89 mL in 1 BOTTLELIQUID891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-116B PURE HAND SANITIZER SHEA BUTTER SCENTED (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]1Current NDC, 2 package rows20240826_1eca1353-3422-4e78-96a5-dd4603c04aac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN1eca1353-3422-4e78-96a5-dd4603c04aac1
581662ethanol 0.7 ML/ML Topical GelSCD1eca1353-3422-4e78-96a5-dd4603c04aac1
581662ethanol 70 % Topical GelSY1eca1353-3422-4e78-96a5-dd4603c04aac1
581662ethyl alcohol 70 % Topical GelSY1eca1353-3422-4e78-96a5-dd4603c04aac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-116-00806840116001 BOTTLE in 1 BOX (80684-116-00) / 89 mL in 1 BOTTLE1 bottle2024-08-25NoNoCurrent