FDA.reportPublic FDA data

Alcare Extra Hand Sanitizer

Product NDC
11084-006
Requested package NDC
11084-006-27
11-digit product format
110840006
Labeler code
11084
Product ID
11084-006_c6719624-10da-43d4-9ae1-eae2398d4018
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SC Johnson Professional USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-01
Substance
ALCOHOL
Active strength
80 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
Alcare Extra Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL80 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
1039339Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1c8e5d0-a766-4bf0-a385-b7b8940a0e2cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-006-01Alcare Extra Hand Sanitizer47 mL in 1 BOTTLE, PLASTICSOLUTION476
11084-006-12Alcare Extra Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION10006
11084-006-13Alcare Extra Hand Sanitizer1 in 1 KITSOLUTION16
11084-006-13Alcare Extra Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION10006
11084-006-14Alcare Extra Hand Sanitizer2 in 1 BOXSOLUTION26
11084-006-14Alcare Extra Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION10006
11084-006-27Alcare Extra Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION10006
11084-006-40Alcare Extra Hand Sanitizer400 mL in 1 BOTTLE, PLASTICSOLUTION4006
11084-006-66Alcare Extra Hand Sanitizer1000 mL in 1 BOTTLESOLUTION10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-006ALCARE EXTRA HAND SANITIZER (ALCOHOL) SOLUTION [SC JOHNSON PROFESSIONAL USA, INC.]5Current NDC, Legacy NDC, 9 package rows20241228_b1c8e5d0-a766-4bf0-a385-b7b8940a0e2c.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
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA, Inc.b1c8e5d0-a766-4bf0-a385-b7b8940a0e2c2025-10-06WarningsExact identifier
ndc (package): 11084-006-27
ndc (product): 11084-006
ndc11 (package): 11084000627

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNb1c8e5d0-a766-4bf0-a385-b7b8940a0e2c6
1039339ethanol 0.8 ML/ML Topical SolutionSCDb1c8e5d0-a766-4bf0-a385-b7b8940a0e2c6
1039339ethanol 80 % Topical SolutionSYb1c8e5d0-a766-4bf0-a385-b7b8940a0e2c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-006-27110840006271000 mL in 1 BOTTLE, PLASTIC (11084-006-27) 1000 ml2017-03-012026-12-31NoNoCurrent