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
Ingredient	Strength
ALCOHOL	62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d83b133-1240-4ec8-9fca-e4cbb84f6caf	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76138-116-03	2024-01-30	C162847	48780-1	1030e365-5fff-111a-e063-dadaa90a10e2	5406 hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76138-116-03	5406 hand sanitizer	30 mL in 1 CONTAINER	GEL	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76138-116	5406 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]	3	Current NDC, Legacy NDC, 1 package rows	20240712_8d83b133-1240-4ec8-9fca-e4cbb84f6caf.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5406 hand sanitizer	ETHYL ALCOHOL	Innovation Specialties	8d83b133-1240-4ec8-9fca-e4cbb84f6caf	2024-07-10	Warnings	Exact identifier ndc (product): 76138-116

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581660	ethanol 62 % Topical Gel	PSN	8d83b133-1240-4ec8-9fca-e4cbb84f6caf	3
581660	ethanol 0.62 ML/ML Topical Gel	SCD	8d83b133-1240-4ec8-9fca-e4cbb84f6caf	3
581660	ethanol 62 % Topical Gel	SY	8d83b133-1240-4ec8-9fca-e4cbb84f6caf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76138-116-03	76138011603	30 mL in 1 CONTAINER (76138-116-03)	30 ml	2018-07-11	0000-00-00	No	No	Current