FDA.reportPublic FDA data

Sterillium comfort

Product NDC
65616-010
Requested package NDC
65616-010-07
11-digit product format
656160010
Labeler code
65616
Product ID
65616-010_4cc0e8b6-8640-d9a6-e063-6294a90a9caf
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
BODE Chemie GmbH
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
ALCOHOL
Active strength
85 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsExact identifier
ndc (package): 65616-010-07
ndc (product): 65616-010
ndc11 (package): 65616001007

Additional Listing Data#

Finished product
Yes
Brand name base
Sterillium comfort
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
1041851Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d48dab8-f70a-a2b5-e063-6294a90a1456Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-010-07Sterillium comfort1000 mL in 1 BOTTLE, PUMPGEL10002
65616-010-09Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-17Sterillium comfort4 in 1 CARTONGEL42
65616-010-17Sterillium comfort1000 mL in 1 BOTTLE, PUMPGEL10002
65616-010-18Sterillium comfort1000 mL in 1 BOTTLE, PUMPGEL10002
65616-010-18Sterillium comfort8 in 1 CARTONGEL82
65616-010-20Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-20Sterillium comfort2 in 1 CARTONGEL22
65616-010-21Sterillium comfort4 in 1 CARTONGEL42
65616-010-21Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-22Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-22Sterillium comfort8 in 1 CARTONGEL82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-010STERILLIUM COMFORT (ALCOHOL) GEL [BODE CHEMIE GMBH]1Current NDC, 12 package rows20250205_2d48dab8-f70a-a2b5-e063-6294a90a1456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041851ethanol 85 % Topical GelPSN2d48dab8-f70a-a2b5-e063-6294a90a14562
1041851ethanol 0.85 ML/ML Topical GelSCD2d48dab8-f70a-a2b5-e063-6294a90a14562
1041851ethanol 85 % Topical GelSY2d48dab8-f70a-a2b5-e063-6294a90a14562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65616-010-07656160010071000 mL in 1 BOTTLE, PUMP (65616-010-07) 1000 ml2026-03-16NoNoCurrent