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Isopropyl Alcohol 50 mL/100mL Liquid, 473 mL — NDC 11344-0864-43 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Isopropyl Alcohol 50 mL/100mL Liquid, 473 mL — NDC 11344-864-43 (Billing 11344-0864-43)

by Nice-Pak Products, LLC · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Isopropyl Alcohol 50 mL/100mL Liquid from Nice-Pak Products, LLC, marketed since Jul 1989 and currently FDA-listed. It is this product's only package size.

NDC 11344-0864-43
🏷️ FDA NDC (as labeled) 11344-864-43 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 11344-864-43 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11344 labeler · 864 product · 43 package
Package marketed since
Jul 15, 1989
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 1134486443 3
FDA record last changed
Oct 1, 2026
⚠️
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-0605-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11344-864-43
Product NDC 11344-864
11-digit billing NDC 11344086443
NCPDP billing unit ML — per mL (volume)
Application # M003
SPL Set ID 4b7eca80-5f46-41be-abcb-a1f924667728
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1989-07-15
Route TOPICAL
Dosage form LIQUID
Substance ISOPROPYL ALCOHOL
Why two NDCs? The FDA registers this code as 11344-864-43 — 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 → 11344-0864-43. 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.

Clinical

🧪 What is this product?

This is a topical liquid containing isopropyl alcohol at a concentration of 50 percent. It is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this product category rather than through an individual application. Isopropyl alcohol is commonly used topically as an antiseptic and disinfectant on skin. This product is typically used for cleansing and minor wound care.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11344-0864-43 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 1989-07-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Isopropyl Alcohol 50 mL/100mLthis 11344-0864-43 Nice-Pak 473 ml — — FDA listed —
Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL 49580-0272-02 P 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 51628-4233-01 My 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 51628-4240-01 MY 177 ml — — FDA listed —
Isopropyl 50 mL/100mL 00869-0211-40 Vi-Jon, 355 ml — — Discontinued —
Isopropyl alcohol 50 percent 50 mL/100mL 49035-0271-16 EQUATE 473 ml — — FDA listed —
50% Rubbing 50 mL/100mL 50804-0864-43 Perrigo 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% with Wintergreen 50 mL/100mL 52000-0051-01 Universal 118 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% 50 mL/100mL 52862-0022-03 Home 119 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 Percent 50 mL/100mL 72520-0315-12 JC 355 ml — — FDA listed —
Isopropyl alcohol 50 mL/100mL 55319-0569-16 Family 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 30400-0101-01 Jell 119 ml — — FDA listed —
Novita Isopropyl Alcohol 50% 50 mL/100mL 52410-1050-04 Shield 355 ml — — FDA listed —
Novita 50% Isopropyl Rubbing Alcohol W/ Wintergreen 50 mL/100mL 52410-1051-04 Shield 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 52862-0023-03 Home 119 ml — — FDA listed —
Nexxgen 50% Rubbing Alcohol 50 mL/100mL 83629-0019-32 A 946 ml — — FDA listed —
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin 50 mL/100mL 52000-0412-32 Universal 946 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 58037-0005-01 New 355 ml — — FDA listed —
Rubbing Alcohol 50 Percent 50 mL/100mL 76436-0321-12 Viny 355 ml — — FDA listed —
WISH RUBBING ALCOHOL 50% Winter Green 50 mL/100mL 84809-0010-01 LJ 12 bottles — — FDA listed —
Doue 50% Isopropyl Rubbing Alcohol 50 mL/100mL 87510-0002-01 ONEST 355 ml — — FDA listed —
Isopropyl 50 mL/100mL 37808-0055-43 H 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% 50 mL/100mL 52000-0050-01 Universal 118 ml — — FDA listed —
Universal 50% Rubbing Alcohol 50 mL/100mL 52000-0410-32 Universal 946 ml — — FDA listed —
Doue 50% Isopropyl Rubbing Alcohol With Wintergreen 50 mL/100mL 87510-0003-01 ONEST 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% 50 mL/100mL 51628-4232-01 MY 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 mL/100mL 58037-0002-01 New 355 ml — — FDA listed —
Our Brand 50% Isopropyl Rubbing Alcohol With Wintergreen 50 mL/100mL 85891-0002-01 SPARROW 354 ml — — Discontinued —
Isopropyl 50 mL/100mL 11344-0112-43 Nice-Pak 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 mL/100mL 30400-0100-01 Jell 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 mL/100mL 52000-0801-01 Universal 355 ml — — FDA listed —
Isopropyl 50 mL/100mL 55910-0211-43 Old 473 ml — — FDA listed —
50% Rubbing 50 mL/100mL 55910-0864-38 Old 296 ml — — Discontinued —
50% Isopropyl Alcohol 50 mL/100mL 59640-0864-43 H 473 ml — — FDA listed —
Wish Rubbing Alcohol 50% 50 mL/100mL 84809-0009-01 LJ 12 bottles — — FDA listed —
Our Brand 50% Isopropyl Rubbing Alcohol 50 mL/100mL 85891-0001-01 SPARROW 354 ml — — Discontinued —
50% Rubbing 50 mL/100mL 00869-0864-18 Vi-Jon, 118 ml — — Discontinued —
50 percent Isopropyl alcohol 50 mL/100mL 42681-6573-01 Whole 473 ml — — FDA listed —
Isopropyl alcohol 50 percent 50 mL/100mL 49035-0272-16 EQUATE 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 52000-0802-01 Universal 119 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

🏛️
1989
On the market since
Jul 1989
📍
2026
Currently FDA-listed
37 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.

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 stateswater

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.

Manufacturer & labeler

LabelerNice-Pak Products, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code11344
First marketedJul 1989
Product typeHuman Otc Drug
Portfolio45 products on file

More NDCs from Nice-Pak Products, LLC labeler code 11344

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 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 🤒 Adverse Reactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

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

⏱️ Dosage and Administration 31 words ▾

Directions clean the affected area apply amount of this product on the affected area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

⚠️ Warnings 13 words ▾

Warnings For external use only. If taken internally serious gastric disturbances will result.

🤒 Adverse Reactions 16 words ▾

Adverse reactions Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593 Pat. D675, 101

🧪 Active Ingredient 5 words ▾

Active ingredient Isopropyl alcohol 50%

🧪 Inactive Ingredients 3 words ▾

Inactive ingredient water

🎯 Purpose 4 words ▾

Purpose First aid antiseptic

📄 Ask a Doctor Before Use If 15 words ▾

Ask a doctor before use for deep or puncture wounds, animal bites or serious burns

📄 When Using This Product 32 words ▾

When using this product do not get into eyes do not inhale do not apply over large areas of the body do not use longer than 1 week use only as directed

📄 Stop Use and Ask a Doctor If 12 words ▾

Stop use and ask a doctor if condition persists or gets worse

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 54 words ▾

Flammable keep away from fire or flame, heat spark, electrical do not use as a fuel source

Caution Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

📄 Package Label / Principal Display Panel 85 words ▾

principal display panel swan ® 50% Isopropyl Alcohol First Aid Antiseptic For Rubbing & Massaging Square bottle uses less plastic than a similarly sized round bottle Recyclable (if available in your area) WARNING FLAMMABLE Keep away from heat, spark, electrical, fire or flame Do not use as fuel source CAUTION: Do not point at self or others; product will squirt when squeezed. Use only as directed, in a well-ventilated area; fumes can be harmful 16 FL OZ (1 PT) 473 mL image description image description

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

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 Nice-Pak Products, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nice-Pak Products, 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.
← 11344-0855-86 · Nice-Pak 11344-0870-26 · Nice-Pak →
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.