NDC 56194-0503-04 — Hand Sanitizer ALCOHOL 65 mL/100mL Gel, 946 mL

🆔 Identity & classification

FDA NDC (as labeled) 56194-503-04

Product NDC 56194-503

11-digit billing NDC 56194050304

RxCUI 902574

UNII 3K9958V90M

UPC 0030034945954, 0030034945947, 0030034945930, 0030034945961

Application # 505G(a)(3)

SPL Set ID d384d3f3-a3c8-a98d-e053-2995a90ab9bf

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-12-01

Route TOPICAL

Dosage form GEL

Substance ALCOHOL

Why two NDCs? The FDA registers this code as 56194-503-04 — 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 → 56194-0503-04. 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

LabelerGiant Eagle

FDA application505G(a)(3) (OTC MONOGRAPH DRUG)

Labeler code56194

First marketedDec 2021

Product typeHuman Otc Drug

Portfolio5 products on file

🔎 All NDCs from Giant Eagle

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

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 9E8X80D2L0
A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
UNII 2N8MDB79NA
A synthetic polymer used as a film-coating agent on tablets and capsules. It forms a protective barrier that controls how quickly the medicine dissolves and releases in the digestive system.
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.
UNII 329LCV5BTF
A blend of fragrance compounds used to add pleasant smell to the medicine. Fragrances mask bitter or unpleasant tastes and odors, making the medication easier to take.
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 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 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
UNII 5655G9Y8AQ
A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.
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.

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

The official label also statesWater (Aqua), PEG-6, Fragrance, (Parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer.

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 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

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: 30 ml 59 ml 236 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Hand sanitizer 29ml 01 65 mL/100mL 54860-0405-01	Shenzhen	29 ml	—	—	FDA listed	—
Mango Sorbet Scented Hand Sanitizer 65 mL/100mL 56136-0443-01	Ganzhou	29 ml	—	—	FDA listed	—
Coconut Vanilla Scented Hand Sanitizer 65 mL/100mL 56136-0444-01	Ganzhou	29 ml	—	—	FDA listed	—
Berris And Creamy Scented Hand Sanitizer 65 mL/100mL 56136-0445-01	Ganzhou	29 ml	—	—	FDA listed	—
Strawberry Shortcake Scented Hand Sanitizer 65 mL/100mL 56136-0446-01	Ganzhou	29 ml	—	—	FDA listed	—
Hand Sanitizer 65 mL/100mLthis 56194-0503-04	Giant	946 ml	—	—	FDA listed	—
Kills Hand Sanitizer 65 mL/100mL 58466-0105-08	Dermazone	236 ml	—	—	FDA listed	—
Hand Sanitizer with Aloe 65 g/100g 59958-0500-02	Owen	18500 g	—	—	Discontinued	—
Natural Concepts Hand Sanitizer 650 mg/mL 63148-0516-03	Apollo	59 ml	—	—	FDA listed	—
Hand Sanitizer 65 mL/100mL 65692-1002-01	Raining	29 ml	—	—	FDA listed	—
Orbit Innovations Hand Sanitizer Cotton Candy 65 mL/100mL 73928-0060-01	Kingkey	30 ml	—	—	FDA listed	—
Orbit Innovations Hand Sanitizer Cotton Vanillia 65 mL/100mL 73928-0061-01	Kingkey	30 ml	—	—	FDA listed	—
Orbit Innovations Hand Sanitizer Coconut 65 mL/100mL 73928-0062-01	Kingkey	30 ml	—	—	FDA listed	—
Orbit Innovations Hand Sanitizer Watermelon 65 mL/100mL 73928-0063-01	Kingkey	30 ml	—	—	FDA listed	—
Artnaturals Scent Free Hand Sanitizer .65 mL/mL 74642-0000-01	Virgin	236 ml	—	—	FDA listed	—
Instant Hand Sanitizer .65 mL/mL 75248-0000-00	ICARCOVER	236 ml	—	—	FDA listed	—
Hand Sanitizer .65 mL/mL 77693-0010-00	BeSafe	237 ml	—	—	FDA listed	—
Hand Sanitizer .65 mL/mL 79396-0000-00	BOZZANO	300 ml	—	—	FDA listed	—
P b pure Antibacterial Hand Sanitizer Cucumber Melon Scented .65 mL/mL 80684-0000-01	FOURSTAR	29 ml	—	—	FDA listed	—
P b pure Antibacterial Hand Sanitizer Ocean Breeze Scented .65 mL/mL 80684-0001-01	FOURSTAR	29 ml	—	—	FDA listed	—
P b pure Antibacterial Hand Sanitizer Sweet Pea Scented .65 mL/mL 80684-0002-01	FOURSTAR	29 ml	—	—	FDA listed	—
Sanitizing Wipes Fragrance Free 65 mL/100mL 69366-0316-24	The	50 patches	—	—	FDA listed	—
Sanitizing wipes with aloe Grapefruit Grove 65 mL/100mL 69366-0317-24	The	50 patches	—	—	Discontinued	—
Sanitizing Wipes Grapefruit 65 mL/100mL 69366-0320-24	The	50 ml	—	—	FDA listed	—
Hand Sanitizing Wipe 65 mL/100mL 81339-0100-24	NeatGoods	24 packets	—	—	FDA listed	—
Sanitizing Wipes Lavender 65 mL/100mL 69366-0319-24	The	50 ml	—	—	FDA listed	—
Hand Sanitizer 65 mL/100mL 81339-0101-24	NeatGoods	1 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

🏛️

2021

On the market since

Dec 2021

📍

2026

Currently FDA-listed

5 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 HAND SANITIZER (this brand).

Top reported reactions

Completed Suicide8,244

Toxicity To Various Agents7,784

Drug Abuse6,958

Death2,735

Overdose2,330

Cardio-respiratory Arrest2,150

Intentional Overdose1,955

Age at onset

Neonate26

Infant16

Child17

Adolescent102

Adult3,298

Elderly329

Reporter sex

Male · 54%

Female · 46%

Unknown · 0%

Serious outcomes

Death22,164

Hospitalization9,875

Life-threatening1,623

Disabling246

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
56194-0503-01	30 mL in 1 BOTTLE, PLASTIC (56194-503-01)	2021-12-01	Active
56194-0503-02	59 mL in 1 BOTTLE, PLASTIC (56194-503-02)	2021-12-01	Active
56194-0503-03	236 mL in 1 BOTTLE, PLASTIC (56194-503-03)	2021-12-01	Active
56194-0503-04 You're viewing this	946 mL in 1 BOTTLE, PLASTIC (56194-503-04)	2021-12-01	Active

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

Pack size FAQ

What quantity is in NDC 56194-0503-04?

NDC 56194-0503-04 contains 946 mL — 946 ml in 1 bottle, plastic.

What is the difference between NDC 56194-0503-04 and NDC 56194-0503-01?

Both are Hand Sanitizer ALCOHOL 65 mL/100mL Gel — the drug itself is identical. NDC 56194-0503-04 is the 946 mL package, while NDC 56194-0503-01 is the 30 ml package.

What NDC number is used to bill for this package of Hand Sanitizer ALCOHOL 65 mL/100mL Gel?

Bill NDC 56194-0503-04 — the 11-digit billing format is 56194050304. 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 56194-503-04, 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: 56194-0503-04, written without dashes as 56194050304. 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 56194-0503-04, the first segment (56194) is the labeler code FDA assigned to Giant Eagle; the middle segment (0503) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Giant Eagle. 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 30 ml (56194-0503-01), 59 ml (56194-0503-02), 236 ml (56194-0503-03). 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?

Giant Eagle 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 28 words ▾

Uses For personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

⏱️ Dosage and Administration 29 words ▾

Directions For occasional and personal use. Rub thoroughly into hands for at least 30 seconds. Allow to dry. Children under 6 years should be supervised when using this product.

⚠️ Warnings 106 words ▾

Warnings For external use only. Flammable. Keep away from source of heat or fire.

When using this product When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Do not use Do not use On children less than 2 months of age On open skin wounds On broken or damaged skin. Stop use and ask a doctor Stop use and ask a doctor If irritation or redness develops and lasts. Keep out of reach of children Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

📦 Storage and Handling 15 words ▾

Other information Store at a temperature below 110ºF (43ºC). May discolor certain fabrics or surfaces.

🧪 Active Ingredient 5 words ▾

Active Ingredient Ethyl Alcohol 65%

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients Water (Aqua), PEG-6, Fragrance, (Parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer.

🎯 Purpose 4 words ▾

Purpose Antiseptic, Hand Sanitizer

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

🔗 Related NDC lookups

🧪 All Alcohol NDCsSame ingredient 🏭 All Giant labeler NDCsLabeler code 56194 📖 Read the Alcohol drug informationUses, warnings & side effects