FDA.reportPublic FDA data

InstantFoam Complete PURE

Product NDC
11084-303
Requested package NDC
11084-303-40
11-digit product format
110840303
Labeler code
11084
Product ID
11084-303_c90f89f1-bc7d-4c81-89f7-5f7c5353e6b8
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
SC Johnson Professional USA Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-01
Substance
ALCOHOL
Active strength
80 g/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
InstantFoam Complete PURE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL80 g/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
1663735Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
22eaf210-ff25-4bec-a6d4-65c711d2917fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-303-12InstantFoam Complete PURE1000 mL in 1 BOTTLE, PLASTICLIQUID10004
11084-303-27InstantFoam Complete PURE1000 mL in 1 BOTTLE, PLASTICLIQUID10004
11084-303-40InstantFoam Complete PURE400 mL in 1 BOTTLE, PUMPLIQUID4004
11084-303-66InstantFoam Complete PURE1000 mL in 1 BOTTLE, PLASTICLIQUID10004
11084-303-67InstantFoam Complete PURE1000 mL in 1 CARTRIDGELIQUID10004
11084-303-67InstantFoam Complete PURE1 in 1 KITLIQUID14
11084-303-68InstantFoam Complete PURE2 in 1 BOXLIQUID24
11084-303-68InstantFoam Complete PURE1000 mL in 1 CARTRIDGELIQUID10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-303INSTANTFOAM COMPLETE PURE (ALCOHOL) LIQUID [SC JOHNSON PROFESSIONAL USA INC.]3Current NDC, Legacy NDC, 8 package rows20241228_22eaf210-ff25-4bec-a6d4-65c711d2917f.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
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.22eaf210-ff25-4bec-a6d4-65c711d2917f2025-06-20WarningsExact identifier
ndc (package): 11084-303-40
ndc (product): 11084-303
ndc11 (package): 11084030340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663735ethanol 80 % Topical FoamPSN22eaf210-ff25-4bec-a6d4-65c711d2917f4
1663735ethanol 0.8 ML/ML Topical FoamSCD22eaf210-ff25-4bec-a6d4-65c711d2917f4
1663735ethanol 80 % Topical FoamSY22eaf210-ff25-4bec-a6d4-65c711d2917f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-303-4011084030340400 mL in 1 BOTTLE, PUMP (11084-303-40) 400 ml2019-10-010000-00-00NoNoCurrent