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Latalia Alcohol Antiseptic 80% Sanitizing 80 mL/100mL Liquid, 55 mL — NDC 80016-0005-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Latalia Alcohol Antiseptic 80% Sanitizing 80 mL/100mL Liquid, 55 mL — NDC 80016-005-01 (Billing 80016-0005-01)

by INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD · 55 mL in 1 BOTTLE

This is a package of 55 mL of Latalia Alcohol Antiseptic 80% Sanitizing 80 mL/100mL Liquid from INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD, marketed since Sep 2023 and currently FDA-listed. It is this product's only package size.

NDC 80016-0005-01
🏷️ FDA NDC (as labeled) 80016-005-01 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 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 80016-005-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
80016 labeler · 005 product · 01 package
Package marketed since
Sep 15, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8001600501 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80016-005-01
Product NDC 80016-005
11-digit billing NDC 80016000501
RxCUI 1241663
UNII 3K9958V90M
Application # M003
SPL Set ID 2da50235-5d89-4774-9c92-bb22cee081f1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-15
Route TOPICAL
Dosage form LIQUID
Substance ALCOHOL
Quick answers
  • RxCUI (RxNorm): 1241663
Why two NDCs? The FDA registers this code as 80016-005-01 — 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 → 80016-0005-01. 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 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
80016-0005-01 You're viewing this Main listing 55 mL in 1 BOTTLE 2023-09-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extra Stength Hand Sanitizer Zytec Germ Buster 80 g/100g 50021-0008-01 Empack 51 g — — FDA listed —
Adventure Hand Sanitizer - Unscented 80% .8 mL/mL 77371-0023-01 NICETY 38 ml — — FDA listed —
Adventure Hand Sanitizer - Fragrance 80% .8 mL/mL 77371-0124-01 NICETY 38 ml — — FDA listed —
Latalia Alcohol Antiseptic 80 Sanitizing 80 mL/100mL 80016-0004-00 INTERNATIONAL 200 ml — — FDA listed —
Latalia Alcohol Antiseptic 80% Sanitizing 80 mL/100mLthis 80016-0005-01 INTERNATIONAL 55 ml — — FDA listed —
Hand Sanitizer 80 mL/100mL 77556-0580-01 Astera 30 ml — — FDA listed —
StellaLife Hand Sanitizer 80 mL/100mL 69685-0201-02 StellaLife, 2 ml — — FDA listed —
Hand Sanitizer 80 mL/100mL 75214-0502-12 HANUL 120 ml — — FDA listed —
Alcare Extra Hand Sanitizer 80 mL/100mL 11084-0006-01 SC 47 ml — — FDA listed —
ProGel Max Hand Sanitizer 80 mL/100mL 66353-0117-01 Delta 350 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 BBX060AN9V
    Hydrogen peroxide is a chemical solution used in medicines as a cleansing agent or preservative. It helps prevent bacterial growth and is sometimes used in oral or topical formulations.
  • 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.

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

The official label also statesglycerin, hydrogen peroxide, purified water USP

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

LabelerINTERNATIONAL CONSUMER PRODUCTS (PVT) LTD
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code80016
First marketedSep 2023
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD labeler code 80016

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 📄 Do Not Use 📄 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 21 words ▾

Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

⏱️ Dosage and Administration 29 words ▾

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

⚠️ Warnings 87 words ▾

Warnings For external use only. Flammable. Keep away from heat or flame Do not use in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

🧪 Active Ingredient 7 words ▾

Active ingredient[s] Alcohol 80% v/v Purpose Antiseptic

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 15 words ▾

Do not use in children less than 2 months of age on open skin wounds

📄 When Using This Product 22 words ▾

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

📄 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.

📄 Package Label / Principal Display Panel 4 words ▾

Product label image description

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 Latalia Alcohol Antiseptic 80% Sanitizing (this brand).

Top reported reactions

Toxicity To Various Agents6,004
Completed Suicide5,433
Drug Abuse5,289
Overdose1,888
Death1,594
Intentional Overdose1,540
Cardio-respiratory Arrest1,346

Age at onset

Neonate26
Infant14
Child16
Adolescent92
Adult2,810
Elderly294

Reporter sex

26,728 reports
Male · 55%
Female · 45%
Unknown · 0%

Serious outcomes

Hospitalization8,617
Life-threatening1,403
Disabling212
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,567 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
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 INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD 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.
← 80016-0004-00 · INTERNATIONAL 80016-0006-00 · INTERNATIONAL →
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.