FDA.reportPublic FDA data

Sterillium rub fragrance-free

Product NDC
65616-011
11-digit product format
656160011
Labeler code
65616
Product ID
65616-011_4d2a8460-ac82-4556-e063-6294a90a5f34
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
2025-01-15
Substance
ALCOHOL
Active strength
89.5 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 rub fragrance-freeALCOHOLBODE Chemie GmbH2bc46854-fe65-782b-e063-6294a90a79af2026-03-16WarningsExact 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. When using this product avoid contact with eyes. In case of contact with eyes, flush immediately 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 rub fragrance-free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL89.5 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

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
65616-011-03Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-06Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-07Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-11Sterillium rub fragrance-free2 in 1 CARTONLIQUID22
65616-011-11Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-12Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-12Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-13Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-13Sterillium rub fragrance-free8 in 1 CARTONLIQUID82
65616-011-14Sterillium rub fragrance-free2 in 1 CARTONLIQUID22
65616-011-14Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-15Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-15Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-17Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-17Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-18Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-18Sterillium rub fragrance-free8 in 1 CARTONLIQUID82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-011STERILLIUM RUB FRAGRANCE-FREE (ALCOHOL) LIQUID [BODE CHEMIE GMBH]1Current NDC, 17 package rows20250122_2bc46854-fe65-782b-e063-6294a90a79af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65616-011-0365616001103500 mL in 1 BOTTLE, PUMP (65616-011-03) 500 ml2025-01-15NoNoCurrent
65616-011-06656160011061000 mL in 1 BOTTLE, PUMP (65616-011-06) 1000 ml2025-01-15NoNoCurrent
65616-011-07656160011071000 mL in 1 BOTTLE, PUMP (65616-011-07) 1000 ml2026-03-16NoNoCurrent
65616-011-11656160011112 BOTTLE, PUMP in 1 CARTON (65616-011-11) / 500 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-12656160011124 BOTTLE, PUMP in 1 CARTON (65616-011-12) / 500 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-13656160011138 BOTTLE, PUMP in 1 CARTON (65616-011-13) / 500 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-14656160011142 BOTTLE, PUMP in 1 CARTON (65616-011-14) / 1000 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-15656160011154 BOTTLE, PUMP in 1 CARTON (65616-011-15) / 1000 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-17656160011174 BOTTLE, PUMP in 1 CARTON (65616-011-17) / 1000 mL in 1 BOTTLE, PUMP2026-03-16NoNoCurrent
65616-011-18656160011188 BOTTLE, PUMP in 1 CARTON (65616-011-18) / 1000 mL in 1 BOTTLE, PUMP2026-03-16NoNoCurrent