Over-the-counter drug · OTC MONOGRAPH DRUG
Sterillium comfort (Alcohol) NDC 65616-010
Alcohol 85 mL/100mL · Gel · Topical · BODE Chemie GmbH
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65616-010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65616-0010Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65616-010-07 | 65616001007 | 1000 mL in 1 BOTTLE, PUMP (65616-010-07)Marketed from Mar 16, 2026 | |
| 65616-010-09 | 65616001009 | 475 mL in 1 BOTTLE, PUMP (65616-010-09)Marketed from Feb 3, 2025 | |
| 65616-010-17 | 65616001017 | 4 BOTTLE, PUMP in 1 CARTON (65616-010-17) / 1000 mL in 1 BOTTLE, PUMPMarketed from Mar 16, 2026 | |
| 65616-010-18 | 65616001018 | 8 BOTTLE, PUMP in 1 CARTON (65616-010-18) / 1000 mL in 1 BOTTLE, PUMPMarketed from Mar 16, 2026 | |
| 65616-010-20 | 65616001020 | 2 BOTTLE, PUMP in 1 CARTON (65616-010-20) / 475 mL in 1 BOTTLE, PUMPMarketed from Feb 3, 2025 | |
| 65616-010-21 | 65616001021 | 4 BOTTLE, PUMP in 1 CARTON (65616-010-21) / 475 mL in 1 BOTTLE, PUMPMarketed from Feb 3, 2025 | |
| 65616-010-22 | 65616001022 | 8 BOTTLE, PUMP in 1 CARTON (65616-010-22) / 475 mL in 1 BOTTLE, PUMPMarketed from Feb 3, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sterillium comfort
- Generic name (nonproprietary)
- alcohol
- Active ingredients
- Alcohol — 85 mL/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- BODE Chemie GmbHNDC labeler code 65616
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 65616-010_4cc0e8b6-8640-d9a6-e063-6294a90a9cafSPL ID 4cc0e8b6-8640-d9a6-e063-6294a90a9cafSPL set ID 2d48dab8-f70a-a2b5-e063-6294a90a1456RxCUI 1041851UNII 3K9958V90MUPC 4031678087433
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465616001007followed by a unit qualifier and the quantityPackage 65616-0010-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses • To decrease bacteria on the skin. • Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 65616-010
- What is NDC 65616-010?
- 65616-010 is the product NDC for Sterillium comfort (alcohol), Alcohol 85 mL/100mL gel, listed with the FDA by BODE Chemie GmbH. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sterillium comfort (Alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- BODE Chemie GmbH, NDC labeler code 65616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sterillium comfort?
- 1 other product NDC are listed under this name. See all Sterillium comfort NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sterillium comfort products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sterillium Comfortalcohol | Alcohol 85 mL/100mL | GelTopical | BODE Chemie GmbH | 65616-009 | 65616-0009-0665616-0009-07 |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tartar control plus Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Topco Associates LLC | 76162-855 |
| Chai Latte Scented Clip On Hand Sanitizeralcohol | Alcohol 70 mL/100mL | GelTopical | Fourstar Group USA, Inc. | 80684-062 |
| KeriCure Hand Sanitizeralcohol | Alcohol 70 mL/100mL | SprayTopical | Kericure Inc. | 78280-304 |
| San-A-Gel | Alcohol 67 mL/100mL | LiquidTopical | Misco Industrial, LLC | 82041-693 |
| Alcohol | Alcohol 70 mL/100mL | GelTopical | TARGET CORPORATION INC. | 82442-003 |
| Tork Foam Antibacterialbenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SoapTopical | Essity Professional Hygiene North America LLC | 49351-104 |
| Hair Growth Foamminoxidil | Minoxidil 5 g/100mL | Aerosol, FoamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-008 |
| aromatica hair acondicionador romero con minoxidilminoxidil | Minoxidil 2 mg/473mL | RinseTopical | LABORATORIO MK SRL | 87022-012 |
| XtraCare Hand Sanitizer Antibacterial Moisturize with Vitamin E and Aloealcohol | Alcohol 70 mL/100mL | GelTopical | Rejoice Industries Canada Inc. | 87559-001 |
| Tartar control plus Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Nice-Pak Products, LLC | 11344-855 |
| PURELL Advanced Instant Hand Sanitizeralcohol | Alcohol .7 mL/mL | LiquidTopical | GOJO Industries, Inc. | 21749-807 |
| ATTITUDE Super Leaves Hand Sanitizer Lemon Leavesethyl alcohol | Alcohol 78.8 mL/100mL | SolutionTopical | 9055-7588 Quebec Inc. DBA Attitude | 61649-293 |
| Peepin It Real Disney Villains Maleficentalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-7030 |
| Anti Bacterial Hand Gel Champagne In Parisalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6769 |
| Smart Care 2 HAND SANITIZERS 1.35 FL OZ (CHAMPAGNE TOAST, SPARKLING POMEGRANATE)ethyl alcohol | — | Kit | Ashtel Studios, Inc. | 70108-399 |
| Antibacterial Hand Sanitizerethyl alcohol | Alcohol 620 mg/mL | GelTopical | Zhejiang Ayan Biotech Co.,Ltd. | 70412-112 |
| Wet Wipes Antibacterial Hand Wipes, Travel Packbenzethonium chloride | Benzethonium chloride 1.3 mg/mL | ClothTopical | Global Import Sales LLC | 72146-037 |
| Alcohol | Alcohol 62 mL/100mL | LiquidTopical | Amazon.com Services LLC | 72288-826 |
| Antiseptic Mouthrinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Walmart Inc. | 49035-072 |
| hair treatmentminoxidil | Minoxidil 1 mg/473mL | CreamTopical | LABORATORIO MK SRL | 87022-009 |
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