FDA.reportPublic FDA data

Sterillium comfort

Product NDC
65616-010
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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Flammable, keep away from fire or flame. Do not use in or near the eyes or on mucous membranes. In case of contact, rinse thoroughly with water. Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui1041851

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
65616-010-0965616001009475 mL in 1 BOTTLE, PUMP (65616-010-09) 475 ml2025-02-03NoNoCurrent
65616-010-17656160010174 BOTTLE, PUMP in 1 CARTON (65616-010-17) / 1000 mL in 1 BOTTLE, PUMP2026-03-16NoNoCurrent
65616-010-18656160010188 BOTTLE, PUMP in 1 CARTON (65616-010-18) / 1000 mL in 1 BOTTLE, PUMP2026-03-16NoNoCurrent
65616-010-20656160010202 BOTTLE, PUMP in 1 CARTON (65616-010-20) / 475 mL in 1 BOTTLE, PUMP2025-02-03NoNoCurrent
65616-010-21656160010214 BOTTLE, PUMP in 1 CARTON (65616-010-21) / 475 mL in 1 BOTTLE, PUMP2025-02-03NoNoCurrent
65616-010-22656160010228 BOTTLE, PUMP in 1 CARTON (65616-010-22) / 475 mL in 1 BOTTLE, PUMP2025-02-03NoNoCurrent