HomeNDC LookupIngredientsIsopropyl Alcohol › 10565-0071-16
Isopropyl Alcohol 91 mL/100mL Liquid, 473 mL — NDC 10565-0071-16 package photo

Isopropyl Alcohol 91 mL/100mL Liquid, 473 mL

by Hydrox Laboratories · 473 mL in 1 BOTTLE, PLASTIC (10565-071-16)
NDC 10565-0071-16
🏷️ FDA NDC (as labeled) 10565-071-16 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes5 compare ↓
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 →
⚠️
Other active recalls for Isopropyl Alcohol (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0373-2026
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0604-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0601-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0602-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0600-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0603-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 10565-071-16
Product NDC 10565-071
11-digit billing NDC 10565007116
RxCUI 582901
UNII ND2M416302
UPC 0021599412913
Application # M003
SPL Set ID f2f07464-6bd5-434c-8dea-0ba659c0e549
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-05-19
Route TOPICAL
Dosage form LIQUID
Substance ISOPROPYL ALCOHOL
Why two NDCs? The FDA registers this code as 10565-071-16 — 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 → 10565-0071-16. 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
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

LabelerHydrox Laboratories
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code10565
First marketedMay 2017
Product typeHuman Otc Drug
Portfolio13 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

🧪 What is this product?

This is a topical liquid containing 91% isopropyl alcohol, marketed as an over-the-counter monograph product. Isopropyl alcohol is commonly used as a disinfectant and antiseptic for skin, typically applied to minor cuts, scrapes, and other small wounds or for general cleansing and sanitizing of skin surfaces. The liquid form allows for easy application by rubbing or wiping onto affected areas.

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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statespurified 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 DailyMedingredient 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: 118 ml 237 ml 946 ml 3785 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
Sunmark Isopropyl Alcohol 91 Percent 910 mg/mL 49348-0174-38 Strategic 473 ml $0.005 FDA listed
Isopropyl alcohol 91 mL/100mL 46122-0772-34 AmerisourceBergen 473 ml $0.054 Availability likely
Health Mart Isopropyl Alcohol 91 Percent 910 mg/mL 62011-0272-01 Strategic 473 ml $0.054 Availability likely
Isopropyl alcohol 91 mL/100mL 70677-1250-01 Strategic 473 ml $0.054 Availability likely
Isopropyl alcohol 91 percent 91 mL/100mL 00363-0277-10 Walgreens 296 ml FDA listed
Walgreens 91% Isopropyl Alcohol .91 mL/mL 00363-0381-16 Walgreens 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 00363-0804-43 Walgreens 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 00869-0804-43 Vi-Jon, 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mLthis 10565-0071-16 Hydrox 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 11344-0408-08 Nice-Pak 3785 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 11673-0077-32 TARGET 946 ml FDA listed
Isopropyl Alcohol .91 mg/mL 11673-0804-43 Target 473 ml Discontinued
Isopropyl Alcohol 91 mL/100mL 21130-0804-43 Better 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 21130-0969-32 Safeway, 946 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 21130-0976-16 Safeway, 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 30142-0804-43 The 473 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 30400-0505-01 Jell 946 ml FDA listed
91% Isopropyl Rubbing Alcohol 91 mL/100mL 30400-0601-01 Jell 355 ml FDA listed
Isopropyl Alcohol 91 percent 91 mL/100mL 36800-0077-16 TOP 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 36800-0804-43 Topco 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 37808-0804-43 H 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 41163-0804-43 United 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 41250-0804-43 Meijer, 473 ml Discontinued
91% Isopropyl Alcohol 91 mL/100mL 42507-0820-43 Hy-Vee, 473 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 49035-0277-16 EQUATE 473 ml Discontinued
Isopropyl alcohol 91 percent ReadyInCase 91 mL/100mL 49580-0277-06 P 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 50594-0804-45 Big 946 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 50804-0804-43 Perrigo 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 51316-0277-32 CVS 946 ml FDA listed
American Red Cross Isopropyl Alcohol First Aid Antiseptic 91 mL/100mL 51628-0341-00 My 473 ml FDA listed
91% Isopropyl Rubbing Alcohol 91 mL/100mL 51628-4236-01 MY 355 ml FDA listed
American Redcross 91% Isopropyl Rubbing Alcohol With Wintergreen 91 mL/100mL 51628-4237-01 MY 355 ml FDA listed
Universal Rubbing Alcohol 91 mL/100mL 52000-0406-35 Universal 355 ml FDA listed
Isopropyl alcohol 91 mL/100mL 52000-0804-01 Universal 355 ml FDA listed
MedPride 91% Rubbing Alcohol 91 mL/100mL 52410-4091-05 Shield 475 ml FDA listed
91% Isopropyl Rubbing Alcohol 91 mL/100mL 52862-0028-01 Home 355 ml FDA listed
Isopropyl Rubbing Alcohol 99% With Wintergreen 91 mL/100mL 52862-0029-01 Home 119 ml FDA listed
Isopropyl alcohol 91 mL/100mL 53329-0797-06 Medline 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 53943-0091-16 Discount 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 53943-0804-43 Discount 473 ml Discontinued
Isopropyl alcohol 91 mL/100mL 55319-0571-16 Family 473 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 55910-0277-16 Dolgencorp, 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 55910-0804-43 Old 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 56062-0804-43 Publix 473 ml FDA listed
91% Isopropyl Rubbing Alcohol 91 mL/100mL 58037-0004-01 New 355 ml FDA listed
91% Isopropyl Rubbing Alcohol With Wintergreen 91 mL/100mL 58037-0007-01 New 355 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 59779-0804-38 CVS 295 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 63941-0804-43 Valu 473 ml FDA listed
Germ Attack 91% Isopropyl Alcohol .91 mL/mL 66902-0091-16 Natural 473 ml FDA listed
Rubbing Alcohol 91 percent isopropyl 91 mL/100mL 67091-0307-16 WinCo 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 67091-0804-43 WinCo 473 ml FDA listed
Isopropyl Alcohol .91 mL/mL 67326-0035-00 Degasa, 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 68016-0804-43 Pharmacy 473 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 68196-0277-32 Sam's 946 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 69256-0277-16 Harris 473 ml FDA listed
Isopropyl Rubbing Alcohol 91 percent 91 mL/100mL 70000-0498-01 Cardinal 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 70000-0691-01 Cardinal 946 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 72036-0804-43 HARRIS 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 72288-0904-45 Amazon.com 946 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 72476-0804-43 ADUSA 473 ml FDA listed
Isopropyl Alcohol 91 Percent 910 mg/mL 82645-0914-16 Pharma 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 82749-0004-16 Epic 473 ml FDA listed
91% Isopropyl Alcohol 91 mL/100mL 83324-0173-16 Chain 473 ml FDA listed
Nexxgen 91% Rubbing Alcohol 91 mL/100mL 83629-0016-12 A 355 ml FDA listed
NEXXGEN 91% RUBBING ALCOHOL with Wintergreen 91 mL/100mL 83629-0018-12 A 355 ml FDA listed
Wish Rubbing Alcohol 91% 91 mL/100mL 84809-0011-01 LJ 12 bottles FDA listed
Isopropyl Alcohol 91 mL/100mL 85828-0804-43 Grocery 473 ml FDA listed
Isopropyl Alcohol 91 mL/100mL 87251-0005-16 4 473 ml FDA listed
Wish 91% Isopropyl Rubbing Alcohol 91 mL/100mL 84809-0006-01 LJ 12 bottles FDA listed
Isopropyl Alcohol 91 mL/100mL 79903-0285-10 Walmart 295 ml FDA listed
Isopropyl alcohol 91 percent 91 mL/100mL 49580-4162-02 P 2 bottles FDA listed
Isopropyl Alcohol 91 mL/100mL 87251-0012-08 4 236 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

🏛️
2017
On the market since
May 2017
📍
2026
Currently FDA-listed
9 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 Isopropyl Alcohol — the ingredient across all brands.

Top reported reactions

Toxicity To Various Agents6,023
Completed Suicide5,458
Drug Abuse5,295
Overdose2,039
Vomiting2,012
Fatigue1,967
Confusional State1,960

Age at onset

Neonate50
Infant14
Child21
Adolescent93
Adult3,475
Elderly348

Reporter sex

33,861 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Death17,757
Hospitalization12,418
Life-threatening4,124
Disabling3,043
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 3,510 1,649
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
10565-0071-04 118 mL in 1 BOTTLE, PLASTIC (10565-071-04) 2019-06-05 Active
10565-0071-08 237 mL in 1 BOTTLE, PLASTIC (10565-071-08) 2019-06-05 Active
10565-0071-16 You're viewing this 473 mL in 1 BOTTLE, PLASTIC (10565-071-16) 2017-05-26 Active
10565-0071-32 946 mL in 1 BOTTLE, PLASTIC (10565-071-32) 2017-05-26 Active
10565-0071-99 3785 mL in 1 BOTTLE, PLASTIC (10565-071-99) 2017-05-26 Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 10565-0071-16?
NDC 10565-0071-16 contains 473 mL — 473 ml in 1 bottle, plastic.
What is the difference between NDC 10565-0071-16 and NDC 10565-0071-04?
Both are Isopropyl Alcohol 91 mL/100mL Liquid — the drug itself is identical. NDC 10565-0071-16 is the 473 mL package, while NDC 10565-0071-04 is the 118 ml package.
What NDC number is used to bill for this package of Isopropyl Alcohol 91 mL/100mL Liquid?
Bill NDC 10565-0071-16 — the 11-digit billing format is 10565007116. 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 ✓ 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 10565-071-16, 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: 10565-0071-16, written without dashes as 10565007116. 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 10565-0071-16, the first segment (10565) is the labeler code FDA assigned to Hydrox Laboratories; the middle segment (0071) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Hydrox Laboratories. 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 4 other package presentations of this same product, including 118 ml (10565-0071-04), 237 ml (10565-0071-08), 946 ml (10565-0071-32). 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?
Hydrox Laboratories 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 15 words

Uses first aid to help prevent the risk of infection in: minor cuts scrapes burns

⏱️ Dosage and Administration 11 words

Directions clean the affected area apply 1 to 3 times daily

⚠️ Warnings 96 words

Warnings For external use only Flammable keep away from fire or flame, heat, spark, electrical. Flash point 72°F. Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns When using this product do not get into eyes do not apply over large areas of the body do not use longer than 1 week unless directed by a doctor Stop use and ask a doctor if condition persists or gets worse Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 24 words

Other information does not contain, nor is intended as a substitute for grain or ethyl alcohol will produce serious gastric disturbances if taken internally

🧪 Active Ingredient 5 words

Active ingredient Isopropyl alcohol 91%

🧪 Inactive Ingredients 4 words

Inactive ingredient purified water

🎯 Purpose 4 words

Purpose First Aid Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.