Home › NDC Lookup › Ingredients › Alcohol › 81385-0002-08
CleanGenic Foaming Hand Sanitizer ALCOHOL 62 mL/100mL Liquid, 237 mL — NDC 81385-0002-08 package photo

CleanGenic Foaming Hand Sanitizer ALCOHOL 62 mL/100mL Liquid, 237 mL

by CleanGenic, LLC · 237 mL in 1 BOTTLE (81385-002-08)
NDC 81385-0002-08
🏷️ FDA NDC (as labeled) 81385-002-08 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 81385-002-08
Product NDC 81385-002
11-digit billing NDC 81385000208
RxCUI 616763
UNII 3K9958V90M
Application # 505G(a)(3)
SPL Set ID b982b2ed-6565-326a-e053-2a95a90a72d2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-10
Route TOPICAL
Dosage form LIQUID
Substance ALCOHOL
Why two NDCs? The FDA registers this code as 81385-002-08 — 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 → 81385-0002-08. 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.

🏷️ 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.

🏭 Manufacturer & labeler

LabelerCleanGenic, LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code81385
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio4 products on file
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Chemically they are related, but hand sanitizer is absolutely not safe to drink — it contains alcohol in concentrations that are toxic if swallowed and often includes other ingredi...
  • Is the alcohol in hand sanitizer the same as the alcohol in a drink?
  • Yes — most of these products are specifically labeled 'recommended for repeated use.' Just apply enough to cover your hands and rub until dry. If you notice skin irritation or redn...
  • Can I use hand sanitizer over and over throughout the day?
📖 Read our full Alcohol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4J55VM509S
    A synthetic compound made from diethanolamine and perfluorinated alkyl phosphates. It functions as a surfactant and emulsifier, helping to blend oil and water-based ingredients together in the formulation.
  • UNII JWM00VS7HC
    A plant-derived emulsifier made from coconut oil and glycerin. It helps blend oil and water-based ingredients together and improves how the medicine spreads or absorbs into skin.
  • 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.

3 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWater, glycereth-2-cocoate, DEA-C8-18 Perfluoroalkylethyl Phosphate

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.

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.

💲 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 systemPer mLPer 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
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alcare OR Foamed Antiseptic Handrub 62 g/100g 11084-0802-80 SC 482 g — — FDA listed —
Alcare Plus Foamed Antiseptic Handrub 62 g/100g 11084-0803-36 SC 255 g — — FDA listed —
FoamFresh Alco-Foam Hand Sanitizer 62 mL/100mL 11429-1004-00 Woodbine 400 ml — — FDA listed —
Doctors Kline and Green Board Certified Dermatologist Hand Sanitizer Antiseptic 62 mL/100mL 23667-0104-00 Formulated 222 ml — — Discontinued —
Symmetry Foaming Hand Sanitizer 62 mL/100mL 30805-0003-03 Buckeye 2000 ml — — FDA listed —
Symmetry Foaming Hand Sanitizer-Fragrance Free with Aloe and Vitamin E 62 mL/100mL 30805-0009-04 Buckeye 1200 ml — — FDA listed —
Altra Foaming Hand Sanitizer with Aloe and Vitamin E 62 mL/100mL 30805-0012-04 Buckeye 1200 ml — — FDA listed —
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin E 62 mL/100mL 30805-0013-04 Buckeye 1200 ml — — FDA listed —
Hand Guard Foaming Alcohol Instant Hand Sanitizer 620 mL/L 31507-0024-24 Wechem, 1 l — — FDA listed —
Hand Guard Foaming Instant Hand Sanitizer .62 mL/mL 31507-0585-08 Wechem, 1000 ml — — FDA listed —
Ecolab 62 mL/100mL 47593-0472-41 Ecolab 750 ml — — FDA listed —
eZFoam Foaming Alcohol Hand Sanitizer 62 mL/100mL 50865-0688-09 Kutol 3785 ml — — FDA listed —
Amcon Labs Hand Sanitizer Instant Foam Sanitizer with Alcohol 620 mL/L 51801-0366-18 Nomax, 55 l — — FDA listed —
Scott Moisturizing Foam Hand Sanitizer 62 mL/100mL 55118-0546-63 Kimberly-Clark 6 bottles — — FDA listed —
Foaming Mousse Anti-Bacterial Hand Sanitizer Cherry Scented 62 mL/100mL 56136-0021-01 Ganzhou 50 ml — — FDA listed —
Foaming Mousse Anti-Bacterial Hand Sanitizer Pineapple Scented 62 mL/100mL 56136-0022-01 Ganzhou 50 ml — — FDA listed —
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit Scented 62 mL/100mL 56136-0023-01 Ganzhou 50 ml — — FDA listed —
Alpet E3 Hand Sanitizer Foam 62 mL/100mL 59900-0125-02 Best 208197 ml — — FDA listed —
Simple Hygiene foaming hand Sanitizer 62 .62 mL/mL 60933-0062-01 FULLER 1000 ml — — FDA listed —
Simple Hygiene Hand Sanitizer 620 mg/mL 60933-0220-00 FULLER 1000 ml — — FDA listed —
Foaming Alcohol Hand Sanitizer .62 mL/mL 63900-0002-00 Simoniz 1000 ml — — FDA listed —
Soft Care Foam Instant Hand Sanitizer 62 mL/100mL 64536-7295-04 Diversey, 532 ml — — FDA listed —
WhiskCare 373 620 mL/L 65585-0374-01 Whisk 1 l — — Discontinued —
Aire-Master Foaming Hand Sanitizer Fragrance Free 620 mL/L 65585-0524-01 Whisk 3.785 l — — FDA listed —
Avant Foaming Hand Sanitizer 62 mL/100mL 68306-0109-01 B4 530 ml — — FDA listed —
Hand Sanitizer 62 mL/100mL 69674-0100-01 Saraya 500 ml — — FDA listed —
Servo Stat-Foam 62 mL/100mL 76378-0011-01 Enzyme 59 ml — — FDA listed —
Hillyard Foaming Instant Hand Sanitizer 62 mL/100mL 76402-0410-02 Hillyard 1000 ml — — FDA listed —
CleanGenic Foaming Hand Sanitizer 62 mL/100mL 81385-0000-01 CleanGenic, 3790 ml — — FDA listed —
CleanGenic 1 GALLON HAND SANITIZER 62 mL/100mL 81385-0001-04 CleanGenic, 24 bottles — — FDA listed —
CleanGenic Foaming Hand Sanitizer 62 mL/100mLthis 81385-0002-08 CleanGenic, 237 ml — — FDA listed —
CleanGenic 8 OZ HAND SANITIZER 62 mL/100mL 81385-0003-08 CleanGenic, 24 bottles — — FDA listed —
Transcend Alco-Foam Hand Sanitizer 62 mL/100mL 81792-0001-01 Von 1250 ml — — FDA listed —
Harbor Mist Alco-Foam Hand Sanitizer 62 mL/100mL 81792-0003-01 Von 1250 ml — — FDA listed —
Freeman Packaging Hand Sanitizer 62 mL/100mL 71734-0201-01 JIANGMEN 7.5 ml — — FDA listed —
Afassco Hand Sanitizer 62 mL/100mL 71734-0206-01 JIANGMEN 2 ml — — FDA listed —
antiseptic hand sanitizer 01 62 mL/100mL 82953-0007-01 Cosmuses 10 ml — — FDA listed —
Alcohol 62 mL/100mL 72288-0849-32 Amazon.com 354 ml — — FDA listed —
Symmetry Hand Sanitizer 62 mL/100mL 30805-0001-01 Buckeye 9 ml — — FDA listed —
Alcohol 62 mL/100mL 59450-0471-16 The 89 ml — — Discontinued —
Alcohol 62 mL/100mL 30142-0849-16 The 59 ml — — FDA listed —
Hand Sanitizer 62 mL/100mL 87001-0006-01 HAIAN 35 ml — — FDA listed —
hand sanitizer 01 62 mL/100mL 82953-0015-01 Cosmuses 10 ml — — FDA listed —
Alcohol 62 mL/100mL 11344-0849-16 Nice-Pak 59 ml — — FDA listed —
Alcohol 62 mL/100mL 41163-0826-16 United 59 ml — — FDA listed —
Antibacterial Hand Sanitizer 62 mL/100mL 82953-0001-01 Cosmuses 10 ml — — FDA listed —
Alcohol 62 mL/100mL 00363-0046-16 Walgreen 59 ml — — FDA listed —
Alcohol 62 mL/100mL 79481-0826-01 Meijer, 59 ml — — FDA listed —
Alcohol 62 mL/100mL 72288-0826-32 Amazon.com 354 ml — — FDA listed —
Hydrating and Moisturizing Hand Sanitizer 62 mL/100mL 75112-0010-01 Zhejiang 35 ml — — Discontinued —
Antibacterial Hand Sanitizer 62 mL/100mL 82953-0008-01 Cosmuses 15 ml — — FDA listed —
Antiseptic Hand Sanitizer 62 mL/100mL 83165-0000-00 Hubei 1.03 ml — — FDA listed —
Altra Hand Sanitizer with Aloe and Vitamin E 62 mL/100mL 30805-0014-06 Buckeye 59.2 ml — — FDA listed —
Alcohol 62 mL/100mL 41163-0975-16 United 59 ml — — FDA listed —
Alcohol 62 mL/100mL 79481-0849-01 Meijer, 59 ml — — FDA listed —
GenRx Anti-Bacterial Gel 62 mL/100mL 59088-0299-08 PureTek 118 ml — — FDA listed —
Antibacterial Hand Sanitizer 62 mL/100mL 71160-0188-12 TEKWELD 12 ml — — FDA listed —
Alcohol 62 mL/100mL 11673-0826-16 Target 59 ml — — FDA listed —
Alcohol 62 mL/100mL 55910-0889-48 Old 1005 ml — — Discontinued —
Instant Hand Sanitizer 62 mL/100mL 59898-0420-01 Water-Jel 1728 packets — — 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.

⏳ Availability & generic status

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 years 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.

🔬 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 CleanGenic Foaming Hand Sanitizer (this brand).

Top reported reactions

Toxicity To Various Agents6,004
Completed Suicide5,432
Drug Abuse5,289
Overdose1,887
Death1,594
Intentional Overdose1,541
Cardio-respiratory Arrest1,345

Age at onset

Neonate26
Infant14
Child16
Adolescent92
Adult2,810
Elderly294

Reporter sex

26,729 reports
Male · 55%
Female · 45%
Unknown · 0%

Serious outcomes

Hospitalization8,618
Life-threatening1,403
Reports over time (by year) — tap or hover for the count & year
2025 2026 2,071 1,499
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81385-0002-08 You're viewing this 237 mL in 1 BOTTLE (81385-002-08) 2020-06-10 Active

🧭 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 FDA registers it as 81385-002-08, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 81385-0002-08, written without dashes as 81385000208. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 81385-0002-08, the first segment (81385) is the labeler code FDA assigned to CleanGenic, LLC; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
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 CleanGenic, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CleanGenic, LLC 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.

📄 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
🎯 Indications and Usage 16 words ▾

Uses - For hand washing to decrease the bacteria on skin. - Recommended for repeated use

⏱️ Dosage and Administration 28 words ▾

DIRECTIONS - Pump a small amount of foam into palm of hand - Rub thoroughly over all surfaces of both hands - Rub hands together briskly until dry

⚠️ Warnings 68 words ▾

Warnings Flammable, keep away from fire or flame. For external use only When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if 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 6 words ▾

Active ingredient Ethanol 62% Purpose Antiseptic

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients: Water, glycereth-2-cocoate, DEA-C8-18 Perfluoroalkylethyl Phosphate

🎯 Purpose 2 words ▾

Purpose Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81385-0001-04 · CleanGenic, 81385-0003-08 · CleanGenic, →
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.