Prevantics Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution, 500 pouches
by Professional Disposables International, Inc. · 500 POUCH in 1 CASE (10819-4077-3) / 1.6 mL in 1 POUCH
NDC 10819-4077-03
🏷️ FDA NDC (as labeled)
10819-4077-3
billing pads the package segment with a zero
This package
Contains500 pouches
Pack sizes3 compare ↓
OTC
Brand
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 →
⚠️
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-0651-2026
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-0648-2026
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-0572-2022
🆔 Identity & classification
FDA NDC (as labeled)
10819-4077-3
Product NDC
10819-4077
11-digit billing NDC
10819407703
UNII
MOR84MUD8E, ND2M416302
Application #
NDA021524
SPL Set ID
9841200b-d4c6-b40c-e053-2995a90a5596
Physiologic effect
Decreased Cell Wall Integrity
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-06-01
Route
TOPICAL
Dosage form
SOLUTION
Substance
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Why two NDCs?
The FDA registers this code as 10819-4077-3 — 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 → 10819-4077-03. 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.
🏭 Manufacturer & labeler
LabelerProfessional Disposables International, Inc.
Application holderPROFESSIONAL DISPOSABLES INC
FDA applicationNDA021524 (NDA)
Labeler code10819
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio15 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
- It's an antiseptic skin prep used before surgery or an injection. A healthcare provider applies it to clean the skin and kill bacteria at the site so you're less likely to get an i...
- What is this solution actually used for?
- Because these solutions contain alcohol, which is flammable. If surgical tools that produce heat — like cautery devices or lasers — are used before the solution is fully dry, there...
- Why does the prep area have to dry before the surgery starts?
Patient education
Supplement & herbal interactions
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.
💬 Questions about chlorhexidine gluconate and isopropyl alcohol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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.
💲 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 system | Per mL | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/mL 10819-4076-03 | Professional | 300 pouches | — | — | Discontinued | — |
| Prevantics Swabstick 31.5 mg/mL; .7 mL/mLthis 10819-4077-03 | 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
Jun 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 10819-4077-02 | 500 POUCH in 1 CASE (10819-4077-2) / 1.6 mL in 1 POUCH | 2020-06-01 | Active |
| 10819-4077-03 You're viewing this | 500 POUCH in 1 CASE (10819-4077-3) / 1.6 mL in 1 POUCH | 2020-06-01 | Active |
| 10819-4077-04 | 50 POUCH in 1 BOX (10819-4077-4) / 1.6 mL in 1 POUCH (10819-4077-1) | 2020-06-01 | Active |
Pack size FAQ
What quantity is in NDC 10819-4077-03?
NDC 10819-4077-03 contains 500 pouches — 500 pouch in 1 case / 1.6 ml in 1 pouch.
What is the difference between NDC 10819-4077-03 and NDC 10819-4077-04?
Both are Prevantics Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution — the drug itself is identical. NDC 10819-4077-03 is the 500 pouches package, while NDC 10819-4077-04 is the 50 pouches package.
What NDC number is used to bill for this package of Prevantics Swabstick chlorhexidine gluconate and isopropyl alcohol 31.5 mg/mL; .7 mL/mL Solution?
Bill NDC 10819-4077-03 — the 11-digit billing format is 10819407703. 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 | — Not published for this NDC No photo available yet for this listing. |
| 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.
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 10819-4077-3, 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: 10819-4077-03, written without dashes as 10819407703. 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 10819-4077-03, the first segment (10819) is the labeler code FDA assigned to Professional Disposables International, Inc.; the middle segment (4077) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Professional Disposables International, Inc.. 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 2 other package presentations of this same product, including 50 pouches (10819-4077-04), 500 pouches (10819-4077-02). 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?
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.
📄 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 ▾
Use for the preparation of the patient's skin prior to surgery or injection
⏱️ Dosage and Administration ▾
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 maxi swabstick is approximately: dry site: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm) tear open the pouch to expose the swabstick remove the 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) half way 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 back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes. do not blot or wipe dry discard after a single use
⚠️ Warnings ▾
Warnings For external use only Flammable, keep away from fire or flame Do not use with electrocautery procedures 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.
📦 Storage and Handling ▾
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 ▾
Active ingredients Chlorhexidine gluconate 3.15% w/v Isopropyl alcohol 70% v/v
🧪 Inactive Ingredients ▾
Inactive ingredients USP purified water
🎯 Purpose ▾
Purposes Antiseptic Antiseptic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.