Home › NDC Lookup › Ingredients › Ethyl Alcohol › 65601-0802-88
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Advanced Alcohol Foaming Hand Sanitizer Ethyl .6787 mL/mL Liquid, 500 mL

by Betco Corporation LLC · 500 mL in 1 BOTTLE, PLASTIC (65601-802-88)
NDC 65601-0802-88
🏷️ FDA NDC (as labeled) 65601-802-88 billing pads the product segment with a zero
This package
Contains500 mL Pack sizes4 compare ↓
Also comes in: 1000 ml 65601-0802-29 3785 ml 65601-0802-04 208175 ml 65601-0802-55
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

⚠️
Other active recalls for Ethyl Alcohol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 23, 2025 — Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol (Consumer Product Partners, LLC) · FDA recall D-0458-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65601-802-88
Product NDC 65601-802
11-digit billing NDC 65601080288
UNII 3K9958V90M
UPC 0700427027269, 0700427027542, 0700427031792, 0700427027245 +1 more
Application # 505G(a)(3)
SPL Set ID 0da8eb7f-2e14-a7d5-e063-6294a90a88e7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-29
Route TOPICAL
Dosage form LIQUID
Substance ALCOHOL
Why two NDCs? The FDA registers this code as 65601-802-88 — 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 → 65601-0802-88. 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.

🏭 Manufacturer & labeler

LabelerBetco Corporation LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code65601
First marketedDec 2023
Product typeHuman Otc Drug
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 5WA6R1KL5J
    A synthetic organic compound used as a solvent in pharmaceutical formulations. It helps dissolve or suspend active ingredients and other components to create a uniform, stable medicine.
  • UNII HFL24LW6V5
    A synthetic organic alcohol used as a solvent and preservative in medications. It helps dissolve active ingredients and protects the medicine from microbial contamination during storage.
  • 0.001 mL / 1 mL UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 0.000002 mL / 1 mL UNII 8J6RDU8L9X
    A synthetic green dye used to color medications. It helps make pills and capsules visually distinct so patients can easily identify their medicine.
  • UNII 28N247O58B
    A synthetic alcohol used as a solvent and preservative in liquid medicines. It helps dissolve active ingredients and prevents microbial growth in the formulation.
  • UNII 7U7KU3MWT0
    Hexyl acetate is a synthetic liquid compound used as a solvent and flavoring agent in medicines. It helps dissolve other ingredients and can contribute to the taste or aroma of the formulation.
  • UNII 8SQ0VA4YUR
    A fragrance compound derived from natural sources, used to add pleasant scent to the medicine. It serves as a flavoring or aromatic agent to mask unpleasant tastes or improve the product's sensory appeal.
  • UNII Z92022479Y
    A synthetic fragrance compound used in small amounts to add or improve the scent of the medication, making it more pleasant to taste or smell.
  • UNII 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • 0.25 mL / 1 mL UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII UM4XS5M134
    A synthetic fragrance ingredient derived from linalool, a naturally occurring compound found in plants. It functions as a fragrance component and masking agent to improve the smell and taste appeal of the medicine.
  • 0.2926 mL / 1 mL 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.

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

The official label also statesAloe Barbadensis Leaf Juice, D&C Green #5, PEG 10 Perfluorohexylethyl acrylate copolymer, Perluorohexylethyl alcohol, propylene glycol, 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.

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.
Try another pack size: 1000 ml 3785 ml 208175 ml
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
Advanced Alcohol Foaming Hand Sanitizer .6787 mL/mLthis 65601-0802-88 Betco 500 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.

⏳ Availability & generic status

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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 Advanced Alcohol Foaming Hand Sanitizer (this brand).

Top reported reactions

Drug Abuse48
Toxicity To Various Agents31
Overdose27
Intentional Overdose19
Poisoning Deliberate19
Suicide Attempt19
Completed Suicide18

Age at onset

Adolescent2
Adult30
Elderly5

Reporter sex

0 reports
Male · 61%
Female · 39%

Serious outcomes

Death74
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 23 0
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
65601-0802-04 3785 mL in 1 BOTTLE, PLASTIC (65601-802-04) 2023-12-29 Active
65601-0802-29 1000 mL in 1 BAG (65601-802-29) 2023-12-29 Active
65601-0802-55 208175 mL in 1 DRUM (65601-802-55) 2023-12-29 Active
65601-0802-88 You're viewing this 500 mL in 1 BOTTLE, PLASTIC (65601-802-88) 2024-03-11 Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65601-0802-88?
NDC 65601-0802-88 contains 500 mL — 500 ml in 1 bottle, plastic.
What is the difference between NDC 65601-0802-88 and NDC 65601-0802-29?
Both are Advanced Alcohol Foaming Hand Sanitizer Ethyl .6787 mL/mL Liquid — the drug itself is identical. NDC 65601-0802-88 is the 500 mL package, while NDC 65601-0802-29 is the 1000 ml package.
What NDC number is used to bill for this package of Advanced Alcohol Foaming Hand Sanitizer Ethyl .6787 mL/mL Liquid?
Bill NDC 65601-0802-88 — the 11-digit billing format is 65601080288. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 65601-802-88, 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: 65601-0802-88, written without dashes as 65601080288. 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 65601-0802-88, the first segment (65601) is the labeler code FDA assigned to Betco Corporation LLC; the middle segment (0802) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (88) 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 Betco Corporation LLC. 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 3 other package presentations of this same product, including 1000 ml (65601-0802-29), 3785 ml (65601-0802-04), 208175 ml (65601-0802-55). 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?
Betco Corporation 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 19 words ▾

usage Hand sanitizer to reduce mocroorganisms on the skin.. Use this product when soap and water are not available.

⏱️ Dosage and Administration 26 words ▾

dosage Please read entire label before using thsi product. Place enough product on your palm to tnoroughly cover your hands, Rub hands together briskyl until dry.

⚠️ Warnings 43 words ▾

warnings For external use only. FLAMMABLE. This product contains ethyl alcohol. Keep away from heat or flame. When using this product avoid contact with eyes. If contact occurs rinse thoroughly with water. Stop use and ask a doctor if irritation or rash occurs.

🧪 Active Ingredient 2 words ▾

Ethjyl Alcohol

🧪 Inactive Ingredients 18 words ▾

inactives Aloe Barbadensis Leaf Juice, D&C Green #5, PEG 10 Perfluorohexylethyl acrylate copolymer, Perluorohexylethyl alcohol, propylene glycol, water

🎯 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 ↗
← 65601-0801-04 · Betco 65601-0817-04 · Betco →
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.