AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL

Product NDC
51628-4437
11-digit product format
516284437
Labeler code
51628
Product ID
51628-4437_1ccb9bb3-07e0-d317-e063-6394a90a0c4d
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
MY IMPORTS USA LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-08
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
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL
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
51628-4437-1AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL53 mL in 1 BOTTLEGEL531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-4437AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL (ETHYL ALCOHOL) GEL [MY IMPORTS USA LLC]1Current NDC, 1 package rows20240710_1ccbbc55-3f7d-76d1-e063-6294a90a5590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN1ccbbc55-3f7d-76d1-e063-6294a90a55901
581662ethanol 0.7 ML/ML Topical GelSCD1ccbbc55-3f7d-76d1-e063-6294a90a55901
581662ethanol 70 % Topical GelSY1ccbbc55-3f7d-76d1-e063-6294a90a55901
581662ethyl alcohol 70 % Topical GelSY1ccbbc55-3f7d-76d1-e063-6294a90a55901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51628-4437-15162844370153 mL in 1 BOTTLE (51628-4437-1) 53 ml2024-07-08NoNoCurrent