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Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution, 300 pouches — NDC 10819-4076-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution, 300 pouches — NDC 10819-4076-3 (Billing 10819-4076-03)

by Professional Disposables International, Inc. · 300 POUCH in 1 CASE / 5.1 mL in 1 POUCH

This is a package of 300 pouches of Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution from Professional Disposables International, Inc., no longer marketed (first marketed Jan 2020), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 10819-4076-03
🏷️ FDA NDC (as labeled) 10819-4076-3 billing pads the package segment with a zero
This package
Contains300 pouches Pack sizes2 compare ↓
Main listing for product 10819-4076 · Also comes in: 30 pouches 10819-4076-4
OTC Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 10819-4076-3 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
10819 labeler · 4076 product · 3 package
Package marketed since
Sep 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1081940763 2
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Chlorhexidine Gluconate And Isopropyl Alcohol (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 9, 2026 — Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator (CareFusion 213, LLC) · FDA recall D-0690-2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0652-2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0646-2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0643-2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0650-2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0651-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Feb 4, 2022 · Terminated — cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. (Professional Disposables International, Inc.) · FDA recall D-0570-2022
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2019. 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) 10819-4076-3
Product NDC 10819-4076
11-digit billing NDC 10819407603
RxCUI 1191171, 1366736
UNII MOR84MUD8E, ND2M416302
Application # NDA021524
SPL Set ID 93ca3c07-40b4-3a91-e053-2995a90a0afd
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2019)
Marketing start 2020-01-01
Route TOPICAL
Dosage form SOLUTION
Substance CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Quick answers
  • RxCUI (RxNorm): 1191171
Why two NDCs? The FDA registers this code as 10819-4076-3 — a 5-4-1 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 package segment → 10819-4076-03. 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 Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives, Biguanides and amidines
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
  • These are professional antiseptic products used to clean your skin right before surgery or an injection. The goal is to kill bacteria on the skin's surface to lower the chance of i...
  • The solution contains alcohol, which is flammable. If any surgical equipment that creates heat or sparks — like cautery or laser tools — is used before the area is fully dry, there...
  • Why does the nurse or surgical tech have to let it dry before the procedure starts?
  • Yes — a severe allergic reaction is possible, though not common. Signs to watch for include wheezing, difficulty breathing, swelling of the face, hives, or rash. If any of those ha...
📖 Read our full Chlorhexidine / Isopropyl 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.
Try another pack size: 30 pouches
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
10819-4076-03 You're viewing this Main listing 300 POUCH in 1 CASE / 5.1 mL in 1 POUCH 2023-09-01 — Discontinued by firm
10819-4076-04 10819-4076-4 30 POUCH in 1 BOX / 5.1 mL in 1 POUCH 2023-12-01 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 300 pouches — 300 pouch in 1 case / 5.1 ml in 1 pouch.
How does this package differ from NDC 10819-4076-04?
Both are Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution — the drug itself is identical. This page's package is the 300 pouches one, while NDC 10819-4076-04 is the 30 pouches package.
What NDC number is used to bill for this package of Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution?
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
Prevantics Swab 31.5 mg/mL; .7 mL/mL 10819-1080-01 Professional 100 pouches — — FDA listed —
Prevantics Maxi Swabstick 31.5 mg/mL; .7 mL/mLthis 10819-4076-03 Professional 300 pouches — — Discontinued —
Prevantics Swabstick 31.5 mg/mL; .7 mL/mL 10819-4077-02 Professional 500 pouches — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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 Chlorhexidine / Isopropyl 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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesUSP purified water

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

LabelerProfessional Disposables International, Inc.
Application holderPROFESSIONAL DISPOSABLES INC
FDA applicationNDA021524 (NDA)
Labeler code10819
First marketedJan 2020
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from Professional Disposables International, Inc. labeler code 10819

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Use for the preparation of the patient's skin prior to surgery or injection

⏱️ Dosage and Administration 190 words ▾

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximum treatment area for one swabstick is approximately 8.4 in. x 8.4 in. (21.3 cm by 21.3 cm). tear open the pouch to expose the swabstick remove swabstick from package.

Do not touch the foam tip. prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes, turning the swabstick over (unused side of the foam tip) halfway in the procedure dry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds. moist site: scrub repeatedly for 1 minute with each side of the applicator for a total of 2 minutes.

Allow to air dry for approximately 1.5 minutes. if using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). do not blot or wipe away discard after a single use

⚠️ Warnings ~1 min read ▾

Warnings For external use only Flammable, k eep away from fire or flame To reduce the risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area ​​​ Allergy alert This product may cause a severe allergic reaction.

Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch When using this product keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain.

If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction 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.

Allergy alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

📦 Storage and Handling 20 words ▾

Other information store between 68-77°F (20-25°C) avoid freezing and excessive heat above 104°F (40°C) for hospital and professional use only

🧪 Active Ingredient 10 words ▾

Active ingredients Chlorhexidine gluconate 3.15% w/v Isopropyl alcohol 70% v/v

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients USP purified water

🎯 Purpose 3 words ▾

Purposes Antiseptic Antiseptic

📄 Do Not Use 38 words ▾

Do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch

📄 Ask a Doctor Before Use If 21 words ▾

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

📄 When Using This Product 38 words ▾

When using this product keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

📄 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 97 words ▾

Package/Label Principal Display Panel Prevantics(R) Maxi Swabstick [Chlorhexidine Gluconate (3.15%)* and Isopropyl Alcohol (70%) Swab] Patient preoperative skin preparation Non-sterile solution Packaging is sterile when in sterile kit *equivalent to 161 mg of Chlorhexidine Gluconate per pouch For External Use Only Use for the preparation of the patient's skin prior to surgery or injection Helps reduce bacteria that potentially can cause skin infection For hospital and professional use only Latex free IMPORTANT : See carton for complete Drug Facts and safety information.

Packet Label Box Label Packet (bulk): Insert: packet 1 box 1 Packet 2 Product Insert

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

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) ✓ 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

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 1 other package presentation of this same product, including 30 pouches (10819-4076-04). 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?
Professional Disposables International, Inc. 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.
← 10819-3918-01 · Professional 10819-4077-02 · Professional →
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.