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Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel, 946 mL — NDC 71489-0007-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel, 946 mL — NDC 71489-007-14 (Billing 71489-0007-14)

by Celeste Industries Corporation · 946 mL in 1 BOTTLE

This is a package of 946 mL of Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel from Celeste Industries Corporation, marketed since Jan 2019 and currently FDA-listed.

NDC 71489-0007-14
🏷️ FDA NDC (as labeled) 71489-007-14 billing pads the product segment with a zero
This package
Contains946 mL Pack sizes16 compare ↓
Product page 71489-0007-01 Also comes in: 59 ml 71489-007-03 59 ml 71489-007-07 177 ml 71489-007-02 177 ml 71489-007-08 237 ml 71489-007-04 237 ml 71489-007-09 284 ml 71489-007-01 284 ml 71489-007-10 355 ml 71489-007-05 355 ml 71489-007-11 530 ml 71489-007-15 530 ml 71489-007-16 946 ml 71489-007-13 3785 ml 71489-007-06 3785 ml 71489-007-12
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 71489-007-14 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71489 labeler · 007 product · 14 package
Package marketed since
Jun 30, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7148900714 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71489-007-14
Product NDC 71489-007
11-digit billing NDC 71489000714
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
Quick answers
  • RxCUI (RxNorm): 1860080
Why two NDCs? The FDA registers this code as 71489-007-14 — 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 → 71489-0007-14. 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 59 ml 177 ml 177 ml 237 ml 237 ml 284 ml 284 ml 355 ml 355 ml 530 ml 530 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71489-0007-01 71489-007-01 Main listing 284 mL in 1 BOTTLE, PUMP 2019-01-24 — Active
71489-0007-03 71489-007-03 59 mL in 1 BOTTLE, PUMP 2020-03-25 — Active
71489-0007-07 71489-007-07 59 mL in 1 BOTTLE 2020-06-25 — Active
71489-0007-10 71489-007-10 284 mL in 1 BOTTLE 2020-06-25 — Active
71489-0007-13 71489-007-13 946 mL in 1 BOTTLE, PUMP 2020-06-30 — Active
71489-0007-14 You're viewing this 946 mL in 1 BOTTLE 2020-06-30 — Active
71489-0007-15 71489-007-15 530 mL in 1 BOTTLE 2020-10-14 — Active
71489-0007-16 71489-007-16 530 mL in 1 BOTTLE, PUMP 2020-10-14 — Active
71489-0007-02 71489-007-02 177 mL in 1 BOTTLE 2020-03-25 — Active
71489-0007-04 71489-007-04 237 mL in 1 BOTTLE, PUMP 2020-05-20 — Active
71489-0007-05 71489-007-05 355 mL in 1 BOTTLE, PUMP 2020-03-25 — Active
71489-0007-06 71489-007-06 3785 mL in 1 BOTTLE 2020-03-25 — Active
71489-0007-08 71489-007-08 177 mL in 1 BOTTLE, PUMP 2020-06-25 — Active
71489-0007-09 71489-007-09 237 mL in 1 BOTTLE 2020-06-25 — Active
71489-0007-11 71489-007-11 355 mL in 1 BOTTLE 2020-06-25 — Active
71489-0007-12 71489-007-12 3785 mL in 1 BOTTLE, PUMP 2020-06-25 — Active

Pack size FAQ

What quantity is in this package?
This package contains 946 mL — 946 ml in 1 bottle.
How does this package differ from NDC 71489-0007-03?
Both are Sani Luxe Hand Sanitizer with Alcohol .625 mL/mL Gel — the drug itself is identical. This page's package is the 946 mL one, 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?
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
Sani Luxe Hand Sanitizer with Alcohol .625 mL/mLthis 71489-0007-14 Celeste 946 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.

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

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

More NDCs from Celeste Industries Corporation labeler code 71489

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 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

📄 When Using This Product 30 words ▾

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.

📄 Stop Use and Ask a Doctor If 20 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 43 words ▾

Sani Luxe ® HAND SANITIZER GEL with Alcohol Requires no water or towels. Apply small amount to hands and rub until dry. Kills 99% of germs on contact Caution: Use on hands only. 284ml e PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

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 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.

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) — 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.
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 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 (71489-0007-02). 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.
← 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.