FDA.reportPublic FDA data

InstantFOAM non-alcohol

Product NDC
11084-058
11-digit product format
110840058
Labeler code
11084
Product ID
11084-058_d68dd783-0c3e-4718-b9eb-bc7f6801448c
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Deb USA, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 mL/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11084-058-012019-10-29C16284748780-1960f7f55-c6b9-8e05-e053-dbdaa90a074aDrug Facts
11084-058-052019-10-29C16284748780-1960f7f55-c6b9-8e05-e053-dbdaa90a074aDrug Facts
11084-058-122019-10-29C16284748780-1960f7f55-c6b9-8e05-e053-dbdaa90a074aDrug Facts
11084-058-202019-10-29C16284748780-1960f7f55-c6b9-8e05-e053-dbdaa90a074aDrug Facts
11084-058-272019-10-29C16284748780-1960f7f55-c6b9-8e05-e053-dbdaa90a074aDrug Facts
11084-058-402019-10-29C16284748780-1960f7f55-c6b9-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-058-01InstantFOAM non-alcohol47 mL in 1 BOTTLE, PUMPLIQUID472
11084-058-05InstantFOAM non-alcohol3780 mL in 1 BOTTLE, PLASTICLIQUID37802
11084-058-12InstantFOAM non-alcohol1200 mL in 1 BOTTLE, PLASTICLIQUID12002
11084-058-20InstantFOAM non-alcohol2000 mL in 1 BOTTLE, PLASTICLIQUID20002
11084-058-27InstantFOAM non-alcohol1000 mL in 1 BOTTLE, PLASTICLIQUID10002
11084-058-40InstantFOAM non-alcohol400 mL in 1 BOTTLE, PUMPLIQUID4002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7INSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78INSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RINSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-058INSTANTFOAM NON-ALCOHOL (BENZALKONIUM CHLORIDE) LIQUID PARAGON AERO INSTANT (BENZALKONIUM CHLORIDE) LIQUID HY5 SOAPOPULAR AERO (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]2Legacy NDC, 6 package rows20101012_5f8f5b80-5c15-4a3c-afe5-aecd9a65e3fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN5f8f5b80-5c15-4a3c-afe5-aecd9a65e3fd2
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD5f8f5b80-5c15-4a3c-afe5-aecd9a65e3fd2
1020365benzalkonium chloride 0.13 % Topical FoamSY5f8f5b80-5c15-4a3c-afe5-aecd9a65e3fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11084-058-011108400580147 mL in 1 BOTTLE, PUMP47 mlHistorical
11084-058-05110840058053780 mL in 1 BOTTLE, PLASTIC3780 mlHistorical
11084-058-12110840058121200 mL in 1 BOTTLE, PLASTIC1200 mlHistorical
11084-058-20110840058202000 mL in 1 BOTTLE, PLASTIC2000 mlHistorical
11084-058-27110840058271000 mL in 1 BOTTLE, PLASTIC1000 mlHistorical
11084-058-4011084005840400 mL in 1 BOTTLE, PUMP400 mlHistorical