5406 hand sanitizer

Product NDC
76138-116
11-digit product format
761380116
Labeler code
76138
Product ID
76138-116_1cee6f58-c80a-b22e-e063-6294a90ae32c
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Innovation Specialties
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-11
Substance
ALCOHOL
Active strength
62 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
5406 hand sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581660

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-116-032024-01-30C16284748780-11030e365-5fff-111a-e063-dadaa90a10e25406 hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-116-035406 hand sanitizer30 mL in 1 CONTAINERGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-1165406 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_8d83b133-1240-4ec8-9fca-e4cbb84f6caf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN8d83b133-1240-4ec8-9fca-e4cbb84f6caf3
581660ethanol 0.62 ML/ML Topical GelSCD8d83b133-1240-4ec8-9fca-e4cbb84f6caf3
581660ethanol 62 % Topical GelSY8d83b133-1240-4ec8-9fca-e4cbb84f6caf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-116-037613801160330 mL in 1 CONTAINER (76138-116-03) 30 ml2018-07-110000-00-00NoNoCurrent