FDA.reportPublic FDA data

Sterillium Foam

Product NDC
65616-006
11-digit product format
656160006
Labeler code
65616
Product ID
65616-006_4d2a68b7-91b6-27e1-e063-6394a90a07f7
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
BODE Chemie GmbH
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-25
Substance
ALCOHOL
Active strength
85 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sterillium Foam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL85 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui2200822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-006-03Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-06Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-07Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-11Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-11Sterillium Foam2 in 1 CARTONLIQUID29
65616-006-12Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-12Sterillium Foam4 in 1 CARTONLIQUID49
65616-006-13Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-13Sterillium Foam8 in 1 CARTONLIQUID89
65616-006-14Sterillium Foam2 in 1 CARTONLIQUID29
65616-006-14Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-15Sterillium Foam4 in 1 CARTONLIQUID49
65616-006-15Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-16Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-16Sterillium Foam8 in 1 CARTONLIQUID89
65616-006-17Sterillium Foam4 in 1 CARTONLIQUID49
65616-006-17Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-18Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-18Sterillium Foam8 in 1 CARTONLIQUID89

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-006STERILLIUM FOAM (ALCOHOL) LIQUID [BODE CHEMIE GMBH]6Current NDC, Legacy NDC, 19 package rows20241225_93680cd8-609f-48f2-e053-2995a90aa355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2200822ethanol 85 % Topical FoamPSN93680cd8-609f-48f2-e053-2995a90aa3559
2200822ethanol 0.85 ML/ML Topical FoamSCD93680cd8-609f-48f2-e053-2995a90aa3559
2200822ethanol 85 % Topical FoamSY93680cd8-609f-48f2-e053-2995a90aa3559

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65616-006-0365616000603500 mL in 1 BOTTLE, PUMP (65616-006-03) 500 ml2019-09-250000-00-00NoNoCurrent
65616-006-06656160006061000 mL in 1 BOTTLE, PUMP (65616-006-06) 1000 ml2019-09-250000-00-00NoNoCurrent
65616-006-07656160006071000 mL in 1 BOTTLE, PUMP (65616-006-07) 1000 ml2026-03-16NoNoCurrent
65616-006-11656160006112 BOTTLE, PUMP in 1 CARTON (65616-006-11) / 500 mL in 1 BOTTLE, PUMP2024-12-11NoNoCurrent
65616-006-12656160006124 BOTTLE, PUMP in 1 CARTON (65616-006-12) / 500 mL in 1 BOTTLE, PUMP2024-12-11NoNoCurrent
65616-006-13656160006138 BOTTLE, PUMP in 1 CARTON (65616-006-13) / 500 mL in 1 BOTTLE, PUMP2024-12-11NoNoCurrent
65616-006-14656160006142 BOTTLE, PUMP in 1 CARTON (65616-006-14) / 1000 mL in 1 BOTTLE, PUMP2024-12-11NoNoCurrent
65616-006-15656160006154 BOTTLE, PUMP in 1 CARTON (65616-006-15) / 1000 mL in 1 BOTTLE, PUMP2024-12-11NoNoCurrent
65616-006-16656160006168 BOTTLE, PUMP in 1 CARTON (65616-006-16) / 1000 mL in 1 BOTTLE, PUMP2024-12-11NoNoCurrent
65616-006-17656160006174 BOTTLE, PUMP in 1 CARTON (65616-006-17) / 1000 mL in 1 BOTTLE, PUMP2026-03-11NoNoCurrent
65616-006-18656160006188 BOTTLE, PUMP in 1 CARTON (65616-006-18) / 1000 mL in 1 BOTTLE, PUMP2026-03-11NoNoCurrent