Antiseptic Hand Sanitizer

Product NDC
76138-113
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76138-113DDiscontinued by firm2026-09-09
excluded packagepackage76138-11376138-113-02DDiscontinued by firm2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76138-113-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76138-113-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76138-113-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76138-113-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76138-113-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76138-113-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76138-113-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76138-113-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76138-113-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76138-113-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76138-113-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76138-113-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76138-113-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76138-113-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76138-113-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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#

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 (product): 76138-113

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
76138-113-017613801130159 mL in 1 BOTTLE (76138-113-01) 59 ml2016-01-020000-00-00NoNoCurrent
76138-113-027613801130215 mL in 1 BOTTLE (76138-113-02) 15 ml2016-01-020000-00-00NoNoCurrent
76138-113-037613801130330 mL in 1 BOTTLE (76138-113-03) 30 ml2016-01-020000-00-00NoNoCurrent
76138-113-077613801130753 mL in 1 BOTTLE (76138-113-07) 53 ml2016-01-020000-00-00NoNoCurrent
76138-113-16761380113161 BOTTLE in 1 BAG (76138-113-16) / 15 mL in 1 BOTTLE1 bottle2016-01-020000-00-00NoNoCurrent