FDA.reportPublic FDA data

Antiseptic Hand Sanitizer

Product NDC
76138-113
Requested package NDC
76138-113-16
11-digit product format
761380113
Labeler code
76138
Product ID
76138-113_1cee2804-1509-7fdb-e063-6294a90a1b89
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic 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
b80b88e1-e35c-47de-89ee-314d6054f4ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
76138-113-012024-01-301030e365-4ed9-111a-e063-dadaa90a10e2Antiseptic Hand Sanitizer
76138-113-032024-01-301030e364-fc76-111a-e063-dadaa90a10e2ANTISEPTIC HAND SANITIZER
76138-113-072024-01-301030e365-2279-111a-e063-dadaa90a10e2Antiseptic Hand Sanitizer
76138-113-162024-01-301030e365-1ed6-111a-e063-dadaa90a10e2Antiseptic Hand Sanitizer
76138-113-022021-01-079d75b9d0-fb59-f424-e053-dadaa90a57ceAntiseptic Hand Sanitizer
76138-113-022020-01-319d75b9d0-fb59-f424-e053-dadaa90a57ceAntiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-113-01Antiseptic Hand Sanitizer59 mL in 1 BOTTLEGEL597
76138-113-03ANTISEPTIC HAND SANITIZER30 mL in 1 BOTTLEGEL306
76138-113-07Antiseptic Hand Sanitizer53 mL in 1 BOTTLEGEL536
76138-113-16Antiseptic Hand Sanitizer1 in 1 BAGGEL16
76138-113-16Antiseptic Hand Sanitizer15 mL in 1 BOTTLEGEL156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-113ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]7Current NDC, Legacy NDC, 1 package rows20240712_b80b88e1-e35c-47de-89ee-314d6054f4ce.zip
76138-113ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]6Current NDC, Legacy NDC, 1 package rows20240712_89af8a07-49cd-4b51-9ca7-016f849d7b70.zip
76138-113ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]6Current NDC, Legacy NDC, 1 package rows20240712_10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a.zip
76138-113ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]6Current NDC, Legacy NDC, 2 package rows20240712_5849d19f-5761-4500-9596-e705b78f14ae.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb80b88e1-e35c-47de-89ee-314d6054f4ce2024-07-10WarningsExact identifier
ndc (product): 76138-113
ANTISEPTIC HAND SANITIZERETHYL ALCOHOLInnovation Specialties Inc89af8a07-49cd-4b51-9ca7-016f849d7b702024-07-10WarningsExact identifier
ndc (product): 76138-113
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a2024-07-10WarningsExact identifier
ndc (product): 76138-113
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc5849d19f-5761-4500-9596-e705b78f14ae2024-07-10WarningsExact identifier
ndc (package): 76138-113-16
ndc (product): 76138-113
ndc11 (package): 76138011316

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNb80b88e1-e35c-47de-89ee-314d6054f4ce7
581660ethanol 0.62 ML/ML Topical GelSCDb80b88e1-e35c-47de-89ee-314d6054f4ce7
581660ethanol 62 % Topical GelSYb80b88e1-e35c-47de-89ee-314d6054f4ce7
581660ethanol 62 % Topical GelPSN10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a6
581660ethanol 62 % Topical GelPSN5849d19f-5761-4500-9596-e705b78f14ae6
581660ethanol 62 % Topical GelPSN89af8a07-49cd-4b51-9ca7-016f849d7b706
581660ethanol 0.62 ML/ML Topical GelSCD10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a6
581660ethanol 0.62 ML/ML Topical GelSCD5849d19f-5761-4500-9596-e705b78f14ae6
581660ethanol 0.62 ML/ML Topical GelSCD89af8a07-49cd-4b51-9ca7-016f849d7b706
581660ethanol 62 % Topical GelSY10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a6
581660ethanol 62 % Topical GelSY5849d19f-5761-4500-9596-e705b78f14ae6
581660ethanol 62 % Topical GelSY89af8a07-49cd-4b51-9ca7-016f849d7b706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-113-16761380113161 BOTTLE in 1 BAG (76138-113-16) / 15 mL in 1 BOTTLE1 bottle2016-01-020000-00-00NoNoCurrent