5253 hand sanitizer

Product NDC
76138-117
11-digit product format
761380117
Labeler code
76138
Product ID
76138-117_1cee56d0-ef03-0c14-e063-6394a90a380f
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
2018-07-16
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
5253 hand sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ef15fec-bb7a-424a-a361-88a8f9503b5fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-117-022024-01-30C16284748780-11030e365-1c9a-111a-e063-dadaa90a10e25253 hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-117-025253 hand sanitizer15 mL in 1 BOTTLEGEL153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-1175253 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_3ef15fec-bb7a-424a-a361-88a8f9503b5f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5253 hand sanitizerETHYL ALCOHOLInnovation Specialties3ef15fec-bb7a-424a-a361-88a8f9503b5f2024-07-10WarningsExact identifier
ndc (product): 76138-117

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN3ef15fec-bb7a-424a-a361-88a8f9503b5f3
581660ethanol 0.62 ML/ML Topical GelSCD3ef15fec-bb7a-424a-a361-88a8f9503b5f3
581660ethanol 62 % Topical GelSY3ef15fec-bb7a-424a-a361-88a8f9503b5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-117-027613801170215 mL in 1 BOTTLE (76138-117-02) 15 ml2018-07-160000-00-00NoNoCurrent