Instant Foam Non-alcohol PURE Hand Sanitizer

Product NDC
11084-300
Requested package NDC
11084-300-01
11-digit product format
110840300
Labeler code
11084
Product ID
11084-300_218bf8d3-a6db-4d18-8511-86adad611144
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
SC Johnson Professional USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-15
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11084-30011084-300-01DDiscontinued by firm2026-08-11

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Instant Foam Non-alcohol PURE Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc557f8d-7ebe-4434-a350-602efbbb9c6eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-300-01Instant Foam Non-alcohol PURE Hand Sanitizer47 mL in 1 BOTTLE, PLASTICLIQUID475
11084-300-12Instant Foam Non-alcohol PURE Hand Sanitizer1200 mL in 1 BOTTLE, PLASTICLIQUID12005
11084-300-27Instant Foam Non-alcohol PURE Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10005
11084-300-40Instant Foam Non-alcohol PURE Hand Sanitizer400 mL in 1 BOTTLE, PLASTICLIQUID4005
11084-300-66Instant Foam Non-alcohol PURE Hand Sanitizer1000 mL in 1 BOTTLELIQUID10005
11084-300-97Instant Foam Non-alcohol PURE Hand Sanitizer296 mL in 1 BOTTLE, PLASTICLIQUID2965

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-300INSTANT FOAM NON-ALCOHOL PURE HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [SC JOHNSON PROFESSIONAL USA, INC.]5Current NDC, Legacy NDC, 6 package rows20241220_fc557f8d-7ebe-4434-a350-602efbbb9c6e.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 Foam Non-alcohol PURE Hand SanitizerBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.fc557f8d-7ebe-4434-a350-602efbbb9c6e2024-12-18WarningsExact identifier
ndc (package): 11084-300-01
ndc (product): 11084-300
ndc11 (package): 11084030001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSNfc557f8d-7ebe-4434-a350-602efbbb9c6e5
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCDfc557f8d-7ebe-4434-a350-602efbbb9c6e5
1020365benzalkonium chloride 0.13 % Topical FoamSYfc557f8d-7ebe-4434-a350-602efbbb9c6e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-300-011108403000147 mL in 1 BOTTLE, PLASTIC (11084-300-01) 47 ml2020-04-150000-00-00NoNoCurrent