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Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 75 mg/mL Swab — NDC 84128-0007-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 75 mg/mL Swab — NDC 84128-007-03 (Billing 84128-0007-03)

by XINXIANG XINDA TECHNOLOGY CO.,LTD · 20 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 3 mL in 1 APPLICATOR

This is a package of Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 75 mg/mL Swab from XINXIANG XINDA TECHNOLOGY CO.,LTD, marketed since May 2026 and currently FDA-listed. It is the main listing for this product, which comes in 6 package sizes.

NDC 84128-0007-03
🏷️ FDA NDC (as labeled) 84128-007-03 billing pads the product segment with a zero
This package
Contains3 mL in 1 applicator Pack sizes6 compare ↓
Main listing for product 84128-007 · Also comes in: 6 mL 84128-007-06 10.5 mL 84128-007-10 26 mL 84128-007-26 30 mL 84128-007-30 35 mL 84128-007-35
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 84128-007-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84128 labeler · 007 product · 03 package
Package marketed since
May 13, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
6977191590204
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Povidone-iodine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 19, 2025 — Subpotent drug (Medline Industries, LP) · FDA recall D-0674-2025
Class II · Sep 11, 2024 — Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000. (Zhejiang Jingwei Pharmaceutical Co., Ltd.) · FDA recall D-0013-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84128-007-03
Product NDC 84128-007
11-digit billing NDC 84128000703
RxCUI 1037204
UNII 85H0HZU99M
UPC 6977191590204
Application # M003
SPL Set ID 51c29301-978a-0d46-e063-6394a90ab9e4
Established class (EPC) Antiseptic
Chemical class Iodine
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-13
Route TOPICAL
Dosage form SWAB
Substance POVIDONE-IODINE
Quick answers
  • RxCUI (RxNorm): 1037204
Why two NDCs? The FDA registers this code as 84128-007-03 — 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 → 84128-0007-03. 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 Antiseptic class.

Pharmacologic class Antiseptic
Drug family (ATC) Iodine products, Medicated dressings with antiinfectives, Medicated shampoos
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's an antiseptic that lowers germs on the skin. Depending on the product, it's used to prep skin before surgery, as a hand scrub or hand wash, or as first aid for minor cuts, scr...
  • It goes on the skin, not in your mouth. Swabs are wiped on and thrown away after one use, and scrubs are lathered and rinsed. Follow the directions on your specific product, and do...
  • If it gets in your eyes, ears or mouth, rinse with cold water right away and contact a doctor. It can cause serious or permanent injury. If it's swallowed, get medical help or call...
  • What if it gets in my eyes or I swallow some?
📖 Read our full Povidone-Iodine 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 eachPer 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: 6 mL 10.5 mL 26 mL 30 mL 35 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
84128-0007-03 You're viewing this Main listing 20 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 3 mL in 1 APPLICATOR 2026-05-13 — Active
84128-0007-06 84128-007-06 20 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 6 mL in 1 APPLICATOR 2026-05-13 — Active
84128-0007-10 84128-007-10 10 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 10.5 mL in 1 APPLICATOR 2026-05-13 — Active
84128-0007-26 84128-007-26 10 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 26 mL in 1 APPLICATOR 2026-05-13 — Active
84128-0007-30 84128-007-30 10 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 30 mL in 1 APPLICATOR 2026-05-13 — Active
84128-0007-35 84128-007-35 10 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 35 mL in 1 APPLICATOR 2026-05-13 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 20 bag in 1 box / 1 applicator in 1 bag / 3 ml in 1 applicator.
What NDC number is used to bill for this package of Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 75 mg/mL Swab?
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
Povidone Iodine Scrub .75 mg/mL 34645-1044-01 Jianerkang 3 applicators — — FDA listed —
Povidone Iodine Scrub 7.5 mg/mL 34645-4025-03 Jianerkang 2.5 ml — — FDA listed —
Povidone-Iodine Scrub Sterile 75 mg/g 63517-0252-21 Cardinal 50 pouches — — FDA listed —
Povidone-Iodine Scrub Sterile 75 mg/g 63517-0255-21 Cardinal 75 patches — — FDA listed —
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 75 mg/mLthis 84128-0007-03 XINXIANG 1 applicator — — 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

💡 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 statesPurified 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

LabelerXINXIANG XINDA TECHNOLOGY CO.,LTD
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code84128
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from XINXIANG XINDA TECHNOLOGY CO.,LTD labeler code 84128

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 📄 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 for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

⏱️ Dosage and Administration 207 words ▾

Directions Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Use in a well ventilated area Maximal treatment area for one applicator is approximately 4 in. x 5 in.

(129 cm²). Do not use 3-ml applicator for head and neck surgery Remove applicator from package; do not touch sponge hold the applicator with the sponge down. Open the switch only once to activate the ampules and release the antiseptic.

Wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin Completely wet the treatment area with antiseptic Dry surgical sites(e.g. abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds Moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes Do not allow solution to pool; tuck prep towels to absorb solution, and then remove 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 the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

⚠️ Warnings 166 words ▾

Warnings For external use only. PREP CAREFULLY: Do not use 3-ml applicator for head and neck surgery 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 Do not use On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol For lumbar puncture or in contact with the meninges On open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth.

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 13 words ▾

Other information Store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)

🧪 Active Ingredient 5 words ▾

Active ingredients Povidone-Iodine 7.5% w/w

🧪 Inactive Ingredients 4 words ▾

Inactive ingredients Purified water

🎯 Purpose 2 words ▾

Purposes Antiseptic

📄 Do Not Use 33 words ▾

Do not use On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol For lumbar puncture or in contact with the meninges On open skin wounds or as a general skin cleanser

📄 When Using This Product 36 words ▾

When using this product keep out of eyes, ears, and mouth. 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 21 words ▾

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 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 12 words ▾

84128-007-03 3ml

84128-007-06 6ml

84128-007-10 10.5ml

84128-007-26 26ml

84128-007-30 30ml

84128-007-35 35ml

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

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Betadine (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Betadine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$874.18
Claims incl. refills
38
Beneficiaries
28
Spend / beneficiary
$31.22
Spend / claim
$23.00
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Povidone-Iodine — the ingredient across all brands.

Top reported reactions

Endophthalmitis427
Drug Hypersensitivity382
Toxic Anterior Segment Syndrome283
Rash273
Nausea240
Pain216
Eye Pain201

Age at onset

Neonate13
Infant15
Child10
Adolescent6
Adult308
Elderly163

Reporter sex

4,212 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization1,315
Death457
Life-threatening413
Disabling294
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 360 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 XINXIANG XINDA TECHNOLOGY CO.,LTD. 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 5 other package presentations of this same product, including 1 applicator (84128-0007-06), 1 applicator (84128-0007-10), 1 applicator (84128-0007-26). 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?
XINXIANG XINDA TECHNOLOGY CO.,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.
← 84128-0006-03 · XINXIANG 84128-0008-03 · XINXIANG →
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.