povidine iodine 10 mg/mL Swab
by Dynarex Corporation · 750 BOX in 1 CASE (67777-419-04) / 75 PACKET in 1 BOX (67777-419-03) / .9 mL in 1 PACKET (67777-419-02)
NDC 67777-0419-04
🏷️ FDA NDC (as labeled)
67777-419-04
billing pads the product segment with a zero
This package
Contains.9 mL in 1 packet
Pack sizes4 compare ↓
OTC
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 →
🚨
Active recall for this product.
Class III · Jul 15, 2026 — Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan (Asclemed USA Inc.) · FDA recall D-0713-2026
Class III · May 18, 2026 — Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan (Eugia US LLC) · FDA recall D-0552-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
67777-419-04
Product NDC
67777-419
11-digit billing NDC
67777041904
NCPDP billing unit
EA — each (per item)
RxCUI
797730
UNII
85H0HZU99M
UPC
0616784120225, 0616784120126
Application #
M003
SPL Set ID
564ec54b-353e-45a8-85e8-a39f89488d9c
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
2016-09-13
Route
TOPICAL
Dosage form
SWAB
Substance
POVIDONE-IODINE
GPI-14
92200040009420
GPI class
Povidone-Iodine
GCN Seq No
007216
GCN
29723
HICL code
004265
Ingredient (HICL)
Povidone-Iodine
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5B
Therapeutic class — specific (HIC3)
Topical Preparations,Antibacterials
AHFS code
84:04.92.00
AHFS class
Local Anti-Infectives, Miscellaneous
FDB label name
POVIDONE-IODINE 10% SWABSTICK
FDB brand name
Povidone-Iodine
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 67777-419-04 — 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 → 67777-0419-04. 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.
🏭 Manufacturer & labeler
LabelerDynarex Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code67777
First marketedSep 2016
Product typeHuman Otc Drug
Portfolio60 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
Label name POVIDONE-IODINE 10% SWABSTICK Ingredient Povidone-Iodine
📗 Our plain-language guide HelloPharmacist
- Povidone-iodine is an antiseptic — it kills bacteria on the skin. You'll find it in a lot of different products: surgical scrubs, skin prep solutions and swabs used before procedur...
- What is povidone-iodine actually used for?
- The standard topical products are for external skin use only — keep them away from your eyes, ears, and mouth. That said, the 3M Skin and Nasal Antiseptic is specifically labeled f...
- For first-aid use at home, you should not use povidone-iodine on a wound for more than 7 days unless a doctor or dentist tells you it's okay. If your wound isn't improving after a...
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 povidine iodine?
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 XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
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 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
-
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.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, 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 each | 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 |
|---|---|---|---|---|---|---|
| Henry Schein Povidone-Iodine Swabsticks 1 g/100mL 00404-0119-01 | Henry | 1000 pouches | — | — | FDA listed | — |
| Henry Schein Povidone-Iodine Swabsticks 1 g/100mL 00404-0120-03 | Henry | 500 pouches | — | — | FDA listed | — |
| Henry Schein Povidone-Iodine Prep Pad 1 g/100mL 00404-0121-01 | Henry | 8000 pouches | — | — | FDA listed | — |
| Povidone-Iodine Swabstick 10 mg/mL 10819-3800-01 | Professional | 50 packets | — | — | FDA listed | — |
| PVP Iodine Prep Pad Medium and Large 10 mg/mL 10819-3883-01 | Professional | 100 packets | — | — | FDA listed | — |
| PVP Iodine Prep Swabstick Ones and Threes 10 mg/mL 10819-3885-01 | Professional | 50 packets | — | — | Discontinued | — |
| Profend Nasal Decolonization 10 mg/mL 10819-3888-03 | Professional | 4 tubes | — | — | FDA listed | — |
| POVIDONE IODINE PREP PAD Sterile 100 mg/mL 34645-0022-00 | Jianerkang | 1 patch | — | — | FDA listed | — |
| POVIDONE IODINE SCRUB SWABSTICK 3s 100 mg/mL 34645-0023-00 | Jianerkang | 3 pouches | — | — | FDA listed | — |
| Povidone Iodine Prep Pad 10 mg/100mL 34645-4008-03 | Jianerkang | 4 ml | — | — | FDA listed | — |
| Povidone Iodine Scrub 10 mg/mL 34645-4050-03 | Jianerkang | 6 ml | — | — | FDA listed | — |
| Povidone Iodine Prep Pad 10 g/100g 34645-5500-01 | Jianerkang | 100 patches | — | — | FDA listed | — |
| Povidone Iodine Prep 100 mg/g 34645-5506-00 | Jianerkang | 500 pouches | — | — | FDA listed | — |
| MediChoice PVP Swabsticks 10 g/100g 39892-0802-01 | O&M | 2 g | — | — | FDA listed | — |
| MediChoice PVP Swabsticks 10 g/100g 39892-0804-01 | O&M | 6 g | — | — | FDA listed | — |
| MediChoice Povidone-Iodine Prep Pad 100 mg/mL 39892-0808-01 | O&M | 1 pouch | — | — | FDA listed | — |
| MediChoice PVP 10 g/100g 39892-0811-01 | O&M | 500 patches | — | — | FDA listed | — |
| MediChoice PVP 10 g/100g 39892-0812-02 | O&M | 500 pouches | — | — | FDA listed | — |
| Povidone-Iodine 10 mg/mL 46414-7777-02 | James | 100 vials | — | — | FDA listed | — |
| Medi-First PVP Iodine Wipes 10 mg/mL 47682-0267-12 | Unifirst-First | 10 packets | — | — | FDA listed | — |
| PVP Iodine .1 g/g 50332-0047-00 | HART | 10 packets | — | — | FDA listed | — |
| Povidone-Iodine Prep Pads Medium 10 mg/mL 51662-1667-01 | HF | 2 packets | — | — | FDA listed | — |
| Aplicare 10 mg/g 52380-0946-03 | Aplicare | 3 applicators | — | — | FDA listed | — |
| MedPride PrepPads .1 g 52410-4115-03 | Shield | 100 solutions | — | — | FDA listed | — |
| Medline 10 mg/mL 53329-0232-30 | Medline | 100 packets | — | — | FDA listed | — |
| Medline 10 mg/mL 53329-0234-09 | Medline | 1 applicator | — | — | FDA listed | — |
| Povidone-Iodine Prep Pads Medium 10 mg/mL 53329-0941-09 | Medline | 1 ml | — | — | FDA listed | — |
| Povidone-Iodine Swabsticks Singles 10 mg/mL 53329-0945-09 | Medline | 1 ml | — | — | FDA listed | — |
| Povidone-Iodine Swabsticks Triples 10 mg/mL 53329-0946-02 | Medline | 3 ml | — | — | FDA listed | — |
| Povidone Iodine .1 g/g 55681-0751-00 | TwinMed | 100 packets | — | — | FDA listed | — |
| Povidone Iodine .1 g 55681-0752-00 | TwinMed | 50 packets | — | — | FDA listed | — |
| Povidone Iodine .1 g 55681-0753-00 | TwinMed | 25 packets | — | — | FDA listed | — |
| Lightning X POVIDONE IODINE WIPE 10 g/100g 59050-0107-01 | Changzhou | 5.5 g | — | — | FDA listed | — |
| Lightning X Iodine Prep Pads 10 g/100g 59050-0121-01 | Changzhou | 5.5 g | — | — | FDA listed | — |
| MK Povidone-Iodine Swabstick Sterile 100 mg/mL 59050-0257-11 | Changzhou | 3 pouches | — | — | FDA listed | — |
| MK Povidone Iodine Swabstick Sterile 100 mg/g 59050-0258-11 | Changzhou | 2.5 g | — | — | FDA listed | — |
| Povidone-lodine Swabsticks Triple 100 mg/g 59050-0261-03 | Changzhou | 3 pouches | — | — | FDA listed | — |
| Povidone Iodine Swabsticks 100 mg/g 59050-0270-00 | Changzhou | 6 g | — | — | FDA listed | — |
| Maokang Povidone Iodine Swabsticks 3s 100 mg/mL 59050-0271-00 | Changzhou | 4.9 ml | — | — | FDA listed | — |
| Povidone Iodine Pad 100 mg/g 59050-0705-01 | Changzhou | 5 g | — | — | FDA listed | — |
| Povidone Iodine Prep Swabstick 1 g/100mL 60913-0051-01 | PHOENIX | 50 pouches | — | — | FDA listed | — |
| Povidone Iodine Prep 1 g/100mL 60913-0999-02 | PHOENIX | 200 packets | — | — | FDA listed | — |
| Lights Povidone Iodine Prep Pad 1 g/100g 61333-0203-01 | Lights | 67 g | — | — | FDA listed | — |
| Lights Povindone Iodine Swabstick 1 g/100g 61333-0212-01 | Lights | 1 applicator | — | — | FDA listed | — |
| Povidone-Iodine Prep Sterile 100 mg/g 63517-0251-21 | Cardinal | 50 patches | — | — | FDA listed | — |
| Povidone-Iodine Prep Sterile 100 mg/g 63517-0254-21 | Cardinal | 4.5 g | — | — | FDA listed | — |
| Povidone-Iodine Prep Pad 10 g/100g 63517-0400-83 | Cardinal | 100 pouches | — | — | FDA listed | — |
| PVP-Iodine Swabstick Threes 1 g/100mL 65517-0033-01 | Dukal | 1000 pouches | — | — | FDA listed | — |
| PVP-I Prep Pads foil-foil 1 g/100mL 65517-0034-01 | Dukal | 8000 pouches | — | — | FDA listed | — |
| Betadine 100 mg/mL 67618-0190-01 | Atlantis | 1 applicator | — | — | FDA listed | — |
| Povidone Iodine Prep Pad 10 g/100g 67777-0002-01 | Dynarex | 100 packets | — | — | FDA listed | — |
| povidine iodine 10 mg/mLthis 67777-0419-04 | Dynarex | 75 packets | — | — | FDA listed | — |
| Swab 10 mg 68599-8630-03 | McKesson | 1 swab | — | — | FDA listed | — |
| Povidone Iodine .1 g 68786-0130-01 | Sion | 50 packets | — | — | FDA listed | — |
| Povidone Iodine .1 g 68786-0140-01 | Sion | 100 packets | — | — | FDA listed | — |
| CVS Povidone Iodine 10 mg/mL 69842-0935-01 | CVS | 6 ml | — | — | FDA listed | — |
| PHARMA CARE Pro Sterile Prep Swabstick POVIDONE-IODINE 10 mg/mL 71884-0059-01 | Enviro | 50 pouches | — | — | FDA listed | — |
| OP First Aid Series Povidone Iodine Prep Pad 100 mg/mL 72459-0012-01 | Yiwu | 1 patch | — | — | FDA listed | — |
| Iodine Prep Pad Antiseptic 100 mg/g 72459-0017-01 | Yiwu | 55 g | — | — | FDA listed | — |
| Op-First Aid Series Povidone Iodine Prep Pad 1 g/100g 72459-0018-01 | Yiwu | 67 g | — | — | FDA listed | — |
| Povidone Iodine Prep Pad 1 g/100g 73288-0002-01 | NINGBO | 2 patches | — | — | FDA listed | — |
| POVIDONE-IODINE PAD- povidone-iodine swab 10 g/100g 82098-0617-10 | Raya | 6 g | — | — | FDA listed | — |
| Antiseptic Povidone-lodine Prep Pad 10 mg/g 82996-0006-01 | Hubei | 1 pouch | — | — | FDA listed | — |
| Povidone Iodine Prep Pad 10 mg/100mg 83170-0003-02 | Hua | 100 patches | — | — | FDA listed | — |
| Povidone-Iodine Pad Sterile 10 g/100g 83446-0101-01 | JINHUA | 10000 pouches | — | — | FDA listed | — |
| Everlit Care Products Iodine Prep Pad .54 g 83807-0012-01 | EVERLIT | 1 cloth | — | — | FDA listed | — |
| Everlit Survival Iodine Prep Pads .54 g 83807-0023-01 | EVERLIT | 1 cloth | — | — | FDA listed | — |
| Antiseptic Povidone Iodine Prep Pad 100 mg/g 84219-0006-00 | M-star | 1 patch | — | — | FDA listed | — |
| Proheal Povidone Iodine Swabstick 1 g/100mL 86173-0003-10 | Click | 60 pouches | — | — | 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
🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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.
🔬 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 Povidine iodine — the ingredient across all brands.
Top reported reactions
Reporter sex
Female · 100%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67777-0419-04 You're viewing this | 750 BOX in 1 CASE (67777-419-04) / 75 PACKET in 1 BOX (67777-419-03) / .9 mL in 1 PACKET (67777-419-02) | 2016-09-13 | Active |
| 67777-0419-11 | 500 BOX in 1 CASE (67777-419-11) / 50 PACKET in 1 BOX (67777-419-10) / .3 mL in 1 PACKET (67777-419-01) | 2016-09-13 | Active |
| 67777-0419-03 | 25 PACKET in 1 BOX (67777-419-03) / .9 mL in 1 PACKET (67777-419-02) | 2016-09-13 | Active |
| 67777-0419-10 | 50 PACKET in 1 BOX (67777-419-10) / .3 mL in 1 PACKET (67777-419-01) | 2016-09-13 | Active |
Pack size FAQ
What quantity is in NDC 67777-0419-04?
NDC 67777-0419-04 is listed by the FDA — 750 box in 1 case / 75 packet in 1 box / .9 ml in 1 packet.
What NDC number is used to bill for this package of povidine iodine 10 mg/mL Swab?
Bill NDC 67777-0419-04 — the 11-digit billing format is 67777041904. 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 | ✓ 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 FDA registers it as 67777-419-04, 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: 67777-0419-04, written without dashes as 67777041904. 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 67777-0419-04, the first segment (67777) is the labeler code FDA assigned to Dynarex Corporation; the middle segment (0419) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Dynarex 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 3 other package presentations of this same product, including 25 packets (67777-0419-03), 50 packets (67777-0419-11), 50 packets (67777-0419-10). 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?
Dynarex 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.
📄 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
🎯 Indications and Usage ▾
For use as an first aid antiseptic pre-operative skin preperation
⏱️ Dosage and Administration ▾
Directions Povidone iodine: Tear at notch, remove applicator, use only once. As a first aid antiseptic clean affected area apply 1 to 3 times daily may be covered with a sterile bandage, if bandaged let dry. For preoperative patient skin preparation clean area apply to operative site prior to surgery using the applicator
⚠️ Warnings ▾
Warnings: Section Text FOR EXTERNAL USE ONLY
🧪 Active Ingredient ▾
Section Text Active Ingredient Purpose Povidone Iodine 10% w/v (9.85% w/w/) Antiseptic
🧪 Inactive Ingredients ▾
Inactive Ingredients Inactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, water
🎯 Purpose ▾
Purpose: Purpose: First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infections.
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.