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Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel, 177 mL — NDC 71489-0007-02 package photo

Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel, 177 mL

by Celeste Industries Corporation · 177 mL in 1 BOTTLE (71489-007-02)
NDC 71489-0007-02
🏷️ FDA NDC (as labeled) 71489-007-02 billing pads the product segment with a zero
This package
Contains177 mL Pack sizes16 compare ↓
Also comes in: 59 ml 71489-0007-03 59 ml 71489-0007-07 177 ml 71489-0007-08 237 ml 71489-0007-04 237 ml 71489-0007-09 284 ml 71489-0007-01 284 ml 71489-0007-10 355 ml 71489-0007-05 355 ml 71489-0007-11 530 ml 71489-0007-15 530 ml 71489-0007-16 946 ml 71489-0007-13 946 ml 71489-0007-14 3785 ml 71489-0007-06 3785 ml 71489-0007-12
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

🆔 Identity & classification

FDA NDC (as labeled) 71489-007-02
Product NDC 71489-007
11-digit billing NDC 71489000702
RxCUI 1860080
UNII 3K9958V90M
Application # 505G(a)(3)
SPL Set ID 1a259dcf-4d82-4a42-be1f-0e557e0940bd
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-24
Route CUTANEOUS
Dosage form GEL
Substance ALCOHOL
Why two NDCs? The FDA registers this code as 71489-007-02 — 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 → 71489-0007-02. 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

LabelerCeleste Industries Corporation
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code71489
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio3 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

📗 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 71DD5V995L
    A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 2DQ7O61VHJ
    A synthetic oily compound made from polyethylene glycol and fatty acids. It serves as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the medicine dissolves and absorbs in the body.
  • 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.

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

The official label also statesAqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol May contain hydroxypropylcellulose.

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 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 59 ml 177 ml 237 ml 237 ml 284 ml 284 ml 355 ml 355 ml 530 ml 530 ml 946 ml 946 ml 3785 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
Sani Luxe Hand Sanitizer with Alcohol .625 mL/mLthis 71489-0007-02 Celeste 177 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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 Sani Luxe Hand Sanitizer with Alcohol (this brand).

Top reported reactions

Toxicity To Various Agents6,004
Completed Suicide5,432
Drug Abuse5,289
Overdose1,887
Death1,594
Intentional Overdose1,541
Cardio-respiratory Arrest1,345

Reporter sex

26,729 reports

Serious outcomes

Death15,128
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,655 1,499
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
71489-0007-01 284 mL in 1 BOTTLE, PUMP (71489-007-01) 2019-01-24 Active
71489-0007-03 59 mL in 1 BOTTLE, PUMP (71489-007-03) 2020-03-25 Active
71489-0007-07 59 mL in 1 BOTTLE (71489-007-07) 2020-06-25 Active
71489-0007-10 284 mL in 1 BOTTLE (71489-007-10) 2020-06-25 Active
71489-0007-13 946 mL in 1 BOTTLE, PUMP (71489-007-13) 2020-06-30 Active
71489-0007-14 946 mL in 1 BOTTLE (71489-007-14) 2020-06-30 Active
71489-0007-15 530 mL in 1 BOTTLE (71489-007-15) 2020-10-14 Active
71489-0007-16 530 mL in 1 BOTTLE, PUMP (71489-007-16) 2020-10-14 Active
71489-0007-02 You're viewing this 177 mL in 1 BOTTLE (71489-007-02) 2020-03-25 Active
71489-0007-04 237 mL in 1 BOTTLE, PUMP (71489-007-04) 2020-05-20 Active
71489-0007-05 355 mL in 1 BOTTLE, PUMP (71489-007-05) 2020-03-25 Active
71489-0007-06 3785 mL in 1 BOTTLE (71489-007-06) 2020-03-25 Active
71489-0007-08 177 mL in 1 BOTTLE, PUMP (71489-007-08) 2020-06-25 Active
71489-0007-09 237 mL in 1 BOTTLE (71489-007-09) 2020-06-25 Active
71489-0007-11 355 mL in 1 BOTTLE (71489-007-11) 2020-06-25 Active
71489-0007-12 3785 mL in 1 BOTTLE, PUMP (71489-007-12) 2020-06-25 Active

Pack size FAQ

What quantity is in NDC 71489-0007-02?
NDC 71489-0007-02 contains 177 mL — 177 ml in 1 bottle.
What is the difference between NDC 71489-0007-02 and NDC 71489-0007-03?
Both are Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel — the drug itself is identical. NDC 71489-0007-02 is the 177 mL package, while NDC 71489-0007-03 is the 59 ml package.
What NDC number is used to bill for this package of Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel?
Bill NDC 71489-0007-02 — the 11-digit billing format is 71489000702. 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 71489-007-02, 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: 71489-0007-02, written without dashes as 71489000702. 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 71489-0007-02, the first segment (71489) is the labeler code FDA assigned to Celeste Industries Corporation; the middle segment (0007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Celeste Industries Corporation. 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 15 other package presentations of this same product, including 59 ml (71489-0007-03), 59 ml (71489-0007-07), 177 ml (71489-0007-08). 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?
Celeste Industries Corporation 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 14 words ▾

Uses Recommended for repeated use For hand sanitizing to decrease bacteria on the skin

⏱️ Dosage and Administration 31 words ▾

Directions Children under 6 years of age should be supervised when using this product Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry

⚠️ Warnings 71 words ▾

Warnings For external use only. Flammable. Keep away from open flame and sources of heat. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

📦 Storage and Handling 12 words ▾

Other information Store below 110°F (43°C) May discolor certain fabrics or surfaces.

🧪 Active Ingredient 5 words ▾

Active ingredient Ethyl Alcohol 62.5%

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol May contain hydroxypropylcellulose.

🎯 Purpose 2 words ▾

Purpose Antimicrobial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71489-0006-01 · Celeste 71489-0009-01 · Celeste →
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.