Instant Hand Sanitizer

Product NDC
0404-5991
11-digit product format
004045991
Labeler code
0404
Product ID
0404-5991_2b5c3dc6-90bc-abe9-e063-6294a90af76e
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Henry Schein, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-01
Substance
ALCOHOL
Active strength
665 mL/1000mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0404-5991UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0404-59910404-5991-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Instant Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL665 mL/1000mL

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
616762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e80feb63-2c51-4164-806d-778e39e620e8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-5991-01Instant Hand Sanitizer800 mL in 1 BOXGEL8005

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-5991INSTANT HAND SANITIZER (ALCOHOL) GEL [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 1 package rows20250112_e80feb63-2c51-4164-806d-778e39e620e8.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
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsExact identifier
ndc (product): 0404-5991

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616762ethanol 66.5 % Topical GelPSNe80feb63-2c51-4164-806d-778e39e620e85
616762ethanol 0.665 ML/ML Topical GelSCDe80feb63-2c51-4164-806d-778e39e620e85
616762ethanol 66.5 % Topical GelSYe80feb63-2c51-4164-806d-778e39e620e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-5991-0100404599101800 mL in 1 BOX (0404-5991-01) 800 ml2012-02-010000-00-00NoNoCurrent