Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Sterillium comfort alcohol 85 mL/100mL Gel, 1000 mL — NDC 65616-010-07 (Billing 65616-0010-07)
by BODE Chemie GmbH · 1000 mL in 1 BOTTLE, PUMP
This is a package of 1,000 mL of Sterillium comfort alcohol 85 mL/100mL Gel from BODE Chemie GmbH, marketed since Feb 2025 and currently FDA-listed. It is the main listing for this product, which comes in 7 package sizes.
NDC 65616-0010-07
🏷️ FDA NDC (as labeled)
65616-010-07
billing pads the product segment with a zero
This package
Contains1000 mL
Pack sizes7 compare ↓
Main listing for product 65616-010 · Also comes in:
2 bottles 65616-010-20
4 bottles 65616-010-17
4 bottles 65616-010-21
8 bottles 65616-010-18
8 bottles 65616-010-22
475 ml 65616-010-09
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 65616-010-07 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 65616 labeler · 010 product · 07 package
- Package marketed since
- Mar 16, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 4031678087433
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
65616-010-07
Product NDC
65616-010
11-digit billing NDC
65616001007
RxCUI
1041851
UNII
3K9958V90M
UPC
4031678087433
Application #
505G(a)(3)
SPL Set ID
2d48dab8-f70a-a2b5-e063-6294a90a1456
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-02-03
Route
TOPICAL
Dosage form
GEL
Substance
ALCOHOL
Quick answers
- RxCUI (RxNorm): 1041851
Why two NDCs?
The FDA registers this code as 65616-010-07 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65616-0010-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Other antiseptics and disinfectants class.
Drug family (ATC)
Other antiseptics and disinfectants, Antidotes, Nerve depressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
📗 Our plain-language guide HelloPharmacist
- It depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
- Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
- Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
- Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about alcohol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 65616-0010-07 You're viewing this Main listing | 1000 mL in 1 BOTTLE, PUMP | 2026-03-16 | — | Active |
| 65616-0010-09 65616-010-09 | 475 mL in 1 BOTTLE, PUMP | 2025-02-03 | — | Active |
| 65616-0010-17 65616-010-17 | 4 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP | 2026-03-16 | — | Active |
| 65616-0010-18 65616-010-18 | 8 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP | 2026-03-16 | — | Active |
| 65616-0010-20 65616-010-20 | 2 BOTTLE, PUMP in 1 CARTON / 475 mL in 1 BOTTLE, PUMP | 2025-02-03 | — | Active |
| 65616-0010-21 65616-010-21 | 4 BOTTLE, PUMP in 1 CARTON / 475 mL in 1 BOTTLE, PUMP | 2025-02-03 | — | Active |
| 65616-0010-22 65616-010-22 | 8 BOTTLE, PUMP in 1 CARTON / 475 mL in 1 BOTTLE, PUMP | 2025-02-03 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 1000 mL — 1000 ml in 1 bottle, pump.
How does this package differ from NDC 65616-0010-09?
Both are Sterillium comfort alcohol 85 mL/100mL Gel — the drug itself is identical. This page's package is the 1000 mL one, while NDC 65616-0010-09 is the 475 ml package.
What NDC number is used to bill for this package of Sterillium comfort alcohol 85 mL/100mL Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| PURELL VF PLUS Hand Sanitizer Gel 85 mL/100mL 21749-0837-02 | GOJO | 60 ml | — | — | FDA listed | — |
| PURELL Advanced Hand Sanitizer PRIME DEFENSE 85 mL/100mL 21749-0905-04 | GOJO | 118 ml | — | — | FDA listed | — |
| Spectrum Hand Sanitizer 85 mL/100mL 53329-0003-14 | Medline | 59 ml | — | — | Discontinued | — |
| Sterillium Comfort 85 mL/100mL 65616-0009-06 | BODE | 1000 ml | — | — | FDA listed | — |
| Sterillium comfort 85 mL/100mLthis 65616-0010-07 | BODE | 1000 ml | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Alcohol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 59TL3WG5CO
A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
-
UNII NMQ347994Z
Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
-
UNII Q4R969U9FR
A chelating agent derived from ethylenediamine, used in formulations to bind metal ions and prevent oxidation, helping preserve the medicine's stability and potency over time.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 918X1OUF1E
Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
-
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
-
UNII 24WE03BX2T
Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
-
UNII V42034O9PU
A fatty alcohol derived from coconut or palm oil. It serves as an emulsifier and thickener to help blend oil and water in creams or lotions, and improves the product's texture and consistency.
-
UNII RDH86HJV5Z
Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesacrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
Manufacturer & labeler
LabelerBODE Chemie GmbH
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code65616
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio6 products on file
More NDCs from BODE Chemie GmbH labeler code 65616
- Sterillium Foam Alcohol 85 mL/100mL Liquid NDC 65616-006-03
- Sterillium Med Alcohol 89.5 mL/100mL Liquid NDC 65616-007-03
- Sterillium Rub Fragrance Free ALCOHOL 89.5 mL/100mL Liquid NDC 65616-008-06
- Sterillium Comfort Alcohol 85 mL/100mL Gel NDC 65616-009-06
- Sterillium rub fragrance-free Alcohol 89.5 mL/100mL Liquid NDC 65616-011-03
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses • To decrease bacteria on the skin. • Recommended for repeated use.
⏱️ Dosage and Administration ▾
Directions • Wet hands thoroughly with product and allow to dry without wiping • Supervise children in the use of this product
⚠️ 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.
🧪 Active Ingredient ▾
Active ingredient Ethyl Alcohol 85 % v/v
🧪 Inactive Ingredients ▾
Inactive ingredients acrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, water
🎯 Purpose ▾
Purpose Antiseptic
📄 Do Not Use ▾
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 ▾
Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
Sterillium comfort gel Healthcare personnel Hand Rub Kills > 99.999% of germs in 15 seconds without water. Boosts skin moisture level. Leaves hands feeling soft and healthy.
Dermatologically tested. Hand Antiseptic Gel 85 % v/v ethyl alcohol with moisturizers To decrease bacteria on the skin. Recommended for repeated use.
Read drug facts panel before use. Designed in Germany. Made in USA.
Lot: Use by: BODE NDC 65616-010-09 475 mL 16.06 fl. oz container labelfgel container labelBgel case label4
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Alcohol — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 48%
Female · 52%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BODE Chemie GmbH. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 2 bottles (65616-0010-20), 4 bottles (65616-0010-17), 4 bottles (65616-0010-21). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
BODE Chemie GmbH is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.