FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
76138-112
11-digit product format
761380112
Labeler code
76138
Product ID
76138-112_1cee65af-24b0-7f48-e063-6294a90a4cee
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Innovation Specialties Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-02
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
Antibacterial 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
1020364Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bef34b7-fdd0-41ee-a140-ea82552aab47Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-112-052024-01-30C16284748780-11030e365-5ca0-111a-e063-dadaa90a10e2Antibacterial Hand Sanitizer Spray
76138-112-062024-01-30C16284748780-11030e365-100e-111a-e063-dadaa90a10e2Antibacterial Hand Sanitizer Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-112-05Antibacterial Hand Sanitizer10 mL in 1 BOTTLE, SPRAYSPRAY104
76138-112-06Antibacterial Hand Sanitizer20 mL in 1 BOTTLE, SPRAYSPRAY204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-112ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) SPRAY [INNOVATION SPECIALTIES INC]4Current NDC, Legacy NDC, 1 package rows20240712_9bef34b7-fdd0-41ee-a140-ea82552aab47.zip
76138-112ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) SPRAY [INNOVATION SPECIALTIES INC]4Current NDC, Legacy NDC, 1 package rows20240712_7824f5c7-3650-490f-92cd-46c8ec32d7be.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc9bef34b7-fdd0-41ee-a140-ea82552aab472024-07-10WarningsExact identifier
ndc (product): 76138-112
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc7824f5c7-3650-490f-92cd-46c8ec32d7be2024-07-10WarningsExact identifier
ndc (product): 76138-112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020364ethanol 62 % Topical SprayPSN7824f5c7-3650-490f-92cd-46c8ec32d7be4
1020364ethanol 62 % Topical SprayPSN9bef34b7-fdd0-41ee-a140-ea82552aab474
1020364ethanol 0.62 ML/ML Topical SpraySCD7824f5c7-3650-490f-92cd-46c8ec32d7be4
1020364ethanol 0.62 ML/ML Topical SpraySCD9bef34b7-fdd0-41ee-a140-ea82552aab474
1020364ethanol 62 % Topical SpraySY7824f5c7-3650-490f-92cd-46c8ec32d7be4
1020364ethanol 62 % Topical SpraySY9bef34b7-fdd0-41ee-a140-ea82552aab474
1020364ethyl alcohol 62 % Topical SpraySY7824f5c7-3650-490f-92cd-46c8ec32d7be4
1020364ethyl alcohol 62 % Topical SpraySY9bef34b7-fdd0-41ee-a140-ea82552aab474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-112-057613801120510 mL in 1 BOTTLE, SPRAY (76138-112-05) 10 ml2016-01-020000-00-00NoNoCurrent
76138-112-067613801120620 mL in 1 BOTTLE, SPRAY (76138-112-06) 20 ml2016-01-020000-00-00NoNoCurrent