Sterillium Comfort
- Product NDC
- 65616-009
- 11-digit product format
- 656160009
- Labeler code
- 65616
- Product ID
- 65616-009_3404a277-8586-6960-e063-6294a90ad27e
- 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
- 2019-07-31
- Substance
- ALCOHOL
- Active strength
- 85 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sterillium Comfort
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALCOHOL | 85 mL/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3K9958V90M |
| Rxcui | 1041851 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65616-009-06 | Sterillium Comfort | 1000 mL in 1 BOTTLE, PUMP | GEL | 1000 | | 8 |
| 65616-009-07 | Sterillium Comfort | 1000 mL in 1 BOTTLE, PUMP | GEL | 1000 | | 8 |
| 65616-009-09 | Sterillium Comfort | 475 mL in 1 BOTTLE, PUMP | GEL | 475 | | 8 |
| 65616-009-10 | Sterillium Comfort | 50 mL in 1 BOTTLE, PLASTIC | GEL | 50 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65616-009 | STERILLIUM COMFORT (ALCOHOL) GEL [BODE CHEMIE GMBH] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250502_8efc9f4e-3b20-60ba-e053-2995a90af8b1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65616-009-06 | 65616000906 | 1000 mL in 1 BOTTLE, PUMP (65616-009-06) | 1000 ml | 2019-07-31 | 0000-00-00 | No | No | Current |
| 65616-009-07 | 65616000907 | 1000 mL in 1 BOTTLE, PUMP (65616-009-07) | 1000 ml | 2025-04-30 | | No | No | Current |
| 65616-009-09 | 65616000909 | 475 mL in 1 BOTTLE, PUMP (65616-009-09) | 475 ml | 2019-07-31 | 0000-00-00 | No | No | Current |
| 65616-009-10 | 65616000910 | 50 mL in 1 BOTTLE, PLASTIC (65616-009-10) | 50 ml | 2019-07-31 | 0000-00-00 | No | No | Current |