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Spectrum Hand Sanitizer ethyl alcohol 85 mL/100mL Gel, 1000 mL — NDC 53329-0003-84 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Spectrum Hand Sanitizer ethyl alcohol 85 mL/100mL Gel, 1000 mL — NDC 53329-003-84 (Billing 53329-0003-84)

by Medline Industries, LP · 1000 mL in 1 BOTTLE

This is a package of 1,000 mL of Spectrum Hand Sanitizer ethyl alcohol 85 mL/100mL Gel from Medline Industries, LP, no longer marketed (first marketed Jul 2018), no longer in the FDA NDC Directory.

NDC 53329-0003-84
🏷️ FDA NDC (as labeled) 53329-003-84 billing pads the product segment with a zero
This package
Contains1000 mL Pack sizes3 compare ↓
Product page 53329-0003-14 Also comes in: 59 ml 53329-003-14 1200 ml 53329-003-74
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 53329-003-84 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53329 labeler · 003 product · 84 package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0193489179746
FDA record last changed
Jul 24, 2026
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53329-003-84
Product NDC 53329-003
11-digit billing NDC 53329000384
RxCUI 1041851
UNII 3K9958V90M
UPC 0193489179746
Application # 505G(a)(3)
SPL Set ID 70598373-bc89-07b9-e053-2991aa0a9e9a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2018-07-06
Route TOPICAL
Dosage form GEL
Substance ALCOHOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90975020002900
GPI class Soothe & Cool Body
Quick answers
  • GPI-14 (Medi-Span): 90975020002900
  • RxCUI (RxNorm): 1041851
Why two NDCs? The FDA registers this code as 53329-003-84 — 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 → 53329-0003-84. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
  • Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
  • Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
  • Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
📖 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.

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 gPer 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: 59 ml 1200 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53329-0003-14 53329-003-14 Main listing 59 mL in 1 BOTTLE 2018-07-06 — Discontinued by firm
53329-0003-84 You're viewing this 1000 mL in 1 BOTTLE 2018-07-06 — Discontinued by firm
53329-0003-74 53329-003-74 1200 mL in 1 BOTTLE 2023-08-01 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 1000 mL — 1000 ml in 1 bottle.
How does this package differ from NDC 53329-0003-14?
Both are Spectrum Hand Sanitizer ethyl alcohol 85 mL/100mL Gel — the drug itself is identical. This page's package is the 1000 mL one, while NDC 53329-0003-14 is the 59 ml package.
What NDC number is used to bill for this package of Spectrum Hand Sanitizer ethyl alcohol 85 mL/100mL Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PURELL VF PLUS Hand Sanitizer Gel 85 mL/100mL 21749-0837-02 GOJO 60 ml — — FDA listed —
PURELL Advanced Hand Sanitizer PRIME DEFENSE 85 mL/100mL 21749-0905-04 GOJO 118 ml — — FDA listed —
Spectrum Hand Sanitizer 85 mL/100mLthis 53329-0003-84 Medline 1000 ml — — Discontinued —
Sterillium Comfort 85 mL/100mL 65616-0009-06 BODE 1000 ml — — FDA listed —
Sterillium comfort 85 mL/100mL 65616-0010-07 BODE 1000 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🧪 Avoiding an ingredient? See Alcohol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerMedline Industries, LP
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio120 products on file

More NDCs from Medline Industries, LP labeler code 53329

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 to decrease bacteria on the skin that could cause disease recommended for repeated use

⏱️ Dosage and Administration 21 words ▾

Directions wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision

⚠️ Warnings 77 words ▾

Warnings For external use only. Flammable. Keep away from heat and flame. When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest Stop use and ask a doctor if irritation or redness develops 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 Ethyl alcohol 85% v/v

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, myristyl alcohol, povidone, tetrahydroxypropyl ethylenediamine, water

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 When Using This Product 28 words ▾

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours

📄 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 17 words ▾

Other information do not store above 105ºF may discolor some fabrics harmful to wood finishes and plastics

📄 Package Label / Principal Display Panel 10 words ▾

Package Label Front Label V2 RB23VJO Back Label V2 RB23VJO

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

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 Spectrum 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

236 reports
Male · 61%
Female · 39%

Serious outcomes

Hospitalization99
Death74
Life-threatening10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 21 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 59 ml (53329-0003-14), 1200 ml (53329-0003-74). 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?
Medline Industries, LP 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.
← 53296-0132-00 · Medichem 53329-0009-02 · Medline →
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.