FDA.reportPublic FDA data

InstantFoam Complete PURE

Product NDC
11084-303
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

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 Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui1663735

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

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
11084-303-011108403030147 mL in 1 BOTTLE, PUMP (11084-303-01) 47 ml2019-10-010000-00-00NoNoCurrent
11084-303-12110840303121000 mL in 1 BOTTLE, PLASTIC (11084-303-12) 1000 ml2019-10-010000-00-00NoNoCurrent
11084-303-27110840303271000 mL in 1 BOTTLE, PLASTIC (11084-303-27) 1000 ml2019-10-012027-12-31NoNoCurrent
11084-303-4011084030340400 mL in 1 BOTTLE, PUMP (11084-303-40) 400 ml2019-10-010000-00-00NoNoCurrent
11084-303-66110840303661000 mL in 1 BOTTLE, PLASTIC (11084-303-66) 1000 ml2023-02-17NoNoCurrent
11084-303-67110840303671 CARTRIDGE in 1 KIT (11084-303-67) / 1000 mL in 1 CARTRIDGE1 cartridge2019-10-01NoNoCurrent
11084-303-68110840303682 CARTRIDGE in 1 BOX (11084-303-68) / 1000 mL in 1 CARTRIDGE2 cartridge2019-10-01NoNoCurrent