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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sterillium comfort
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALCOHOL | 85 mL/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3K9958V90M |
| Rxcui | 1041851 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65616-010 | STERILLIUM COMFORT (ALCOHOL) GEL [BODE CHEMIE GMBH] | 1 | Current NDC, 12 package rows | 20250205_2d48dab8-f70a-a2b5-e063-6294a90a1456.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65616-010-07 | 65616001007 | 1000 mL in 1 BOTTLE, PUMP (65616-010-07) | 1000 ml | 2026-03-16 | No | No | Current |
| 65616-010-09 | 65616001009 | 475 mL in 1 BOTTLE, PUMP (65616-010-09) | 475 ml | 2025-02-03 | No | No | Current |
| 65616-010-17 | 65616001017 | 4 BOTTLE, PUMP in 1 CARTON (65616-010-17) / 1000 mL in 1 BOTTLE, PUMP | | 2026-03-16 | No | No | Current |
| 65616-010-18 | 65616001018 | 8 BOTTLE, PUMP in 1 CARTON (65616-010-18) / 1000 mL in 1 BOTTLE, PUMP | | 2026-03-16 | No | No | Current |
| 65616-010-20 | 65616001020 | 2 BOTTLE, PUMP in 1 CARTON (65616-010-20) / 475 mL in 1 BOTTLE, PUMP | | 2025-02-03 | No | No | Current |
| 65616-010-21 | 65616001021 | 4 BOTTLE, PUMP in 1 CARTON (65616-010-21) / 475 mL in 1 BOTTLE, PUMP | | 2025-02-03 | No | No | Current |
| 65616-010-22 | 65616001022 | 8 BOTTLE, PUMP in 1 CARTON (65616-010-22) / 475 mL in 1 BOTTLE, PUMP | | 2025-02-03 | No | No | Current |