FDA.reportPublic FDA data

Sterillium Foam

Product NDC
65616-006
Requested package NDC
65616-006-03
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 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
2200822Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93680cd8-609f-48f2-e053-2995a90aa355Available on FDA.report

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

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
Sterillium FoamALCOHOLBODE Chemie GmbH93680cd8-609f-48f2-e053-2995a90aa3552026-03-16WarningsExact identifier
ndc (package): 65616-006-03
ndc (product): 65616-006
ndc11 (package): 65616000603

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