Sani Luxe Hand Sanitizer with Alcohol

Product NDC
71489-007
Requested package NDC
71489-007-01
11-digit product format
714890007
Labeler code
71489
Product ID
71489-007_1cc045e7-0007-22bc-e063-6394a90a11fa
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
CUTANEOUS
Labeler
Celeste Industries Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-24
Substance
ALCOHOL
Active strength
.625 mL/mL
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
Sani Luxe Hand Sanitizer with Alcohol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.625 mL/mL

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
1860080Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a259dcf-4d82-4a42-be1f-0e557e0940bdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71489-007-01Sani Luxe Hand Sanitizer with Alcohol284 mL in 1 BOTTLE, PUMPGEL28413
71489-007-02Sani Luxe Hand Sanitizer with Alcohol177 mL in 1 BOTTLEGEL17713
71489-007-03Sani Luxe Hand Sanitizer with Alcohol59 mL in 1 BOTTLE, PUMPGEL5913
71489-007-04Sani Luxe Hand Sanitizer with Alcohol237 mL in 1 BOTTLE, PUMPGEL23713
71489-007-05Sani Luxe Hand Sanitizer with Alcohol355 mL in 1 BOTTLE, PUMPGEL35513
71489-007-06Sani Luxe Hand Sanitizer with Alcohol3785 mL in 1 BOTTLEGEL378513
71489-007-07Sani Luxe Hand Sanitizer with Alcohol59 mL in 1 BOTTLEGEL5913
71489-007-08Sani Luxe Hand Sanitizer with Alcohol177 mL in 1 BOTTLE, PUMPGEL17713
71489-007-09Sani Luxe Hand Sanitizer with Alcohol237 mL in 1 BOTTLEGEL23713
71489-007-10Sani Luxe Hand Sanitizer with Alcohol284 mL in 1 BOTTLEGEL28413
71489-007-11Sani Luxe Hand Sanitizer with Alcohol355 mL in 1 BOTTLEGEL35513
71489-007-12Sani Luxe Hand Sanitizer with Alcohol3785 mL in 1 BOTTLE, PUMPGEL378513
71489-007-13Sani Luxe Hand Sanitizer with Alcohol946 mL in 1 BOTTLE, PUMPGEL94613
71489-007-14Sani Luxe Hand Sanitizer with Alcohol946 mL in 1 BOTTLEGEL94613
71489-007-15Sani Luxe Hand Sanitizer with Alcohol530 mL in 1 BOTTLEGEL53013
71489-007-16Sani Luxe Hand Sanitizer with Alcohol530 mL in 1 BOTTLE, PUMPGEL53013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71489-007SANI LUXE HAND SANITIZER WITH ALCOHOL (ALCOHOL) GEL [CELESTE INDUSTRIES CORPORATION]13Current NDC, Legacy NDC, 16 package rows20240709_1a259dcf-4d82-4a42-be1f-0e557e0940bd.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
Sani Luxe Hand Sanitizer with AlcoholALCOHOLCeleste Industries Corporation1a259dcf-4d82-4a42-be1f-0e557e0940bd2024-07-08WarningsExact identifier
ndc (package): 71489-007-01
ndc (product): 71489-007
ndc11 (package): 71489000701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860080ethanol 62.5 % Topical GelPSN1a259dcf-4d82-4a42-be1f-0e557e0940bd13
1860080ethanol 0.625 ML/ML Topical GelSCD1a259dcf-4d82-4a42-be1f-0e557e0940bd13
1860080ethanol 62.5 % Topical GelSY1a259dcf-4d82-4a42-be1f-0e557e0940bd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71489-007-0171489000701284 mL in 1 BOTTLE, PUMP (71489-007-01) 284 ml2019-01-240000-00-00NoNoCurrent