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Sani Professional Hands Instant Sanitizing Wipes Alcohol .7 mL/mL Cloth, 484 mL — NDC 10819-6007-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sani Professional Hands Instant Sanitizing Wipes Alcohol .7 mL/mL Cloth, 484 mL — NDC 10819-6007-1 (Billing 10819-6007-01) · Product 10819-6007

by Professional Disposables International, Inc. · 484 mL in 1 CANISTER (10819-6007-1)

NDC 10819-6007-1 (billing 10819-6007-01) is a package of 484 mL of Sani Professional Hands Instant Sanitizing Wipes Alcohol .7 mL/mL Cloth from Professional Disposables International, Inc., marketed since Mar 2020 and currently FDA-listed. It is the main listing for product NDC 10819-6007, its only package size.

NDC 10819-6007-01
🏷️ FDA NDC (as labeled) 10819-6007-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10819-6007-1
Product NDC 10819-6007
11-digit billing NDC 10819600701
RxCUI 1489307
UNII 3K9958V90M
Application # 505G(a)(3)
SPL Set ID 96d92653-2b7d-6fd0-e053-2995a90ae04d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-03-01
Route TOPICAL
Dosage form CLOTH
Substance ALCOHOL
Quick answers for NDC 10819-6007-1
  • RxCUI (RxNorm): 1489307
  • 11-digit billing NDC: 10819600701
Why two NDCs? The FDA registers this code as 10819-6007-1 — 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 → 10819-6007-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants, Antidotes, Nerve depressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
  • Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
  • Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
  • Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
📖 Read our full Alcohol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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.
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
10819-6007-01 10819-6007-1 You're viewing this Main listing 484 mL in 1 CANISTER (10819-6007-1) 2020-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PDI Sani-Hands Instant Hand Sanitizing Wipes .7 mL/mL 10819-3916-01 Professional 100 packets — — FDA listed —
PDI Sani Hands .7 mL/mL 10819-3918-01 Professional 20 applicators — — FDA listed —
Sani Professional Hands Instant Sanitizing Wipes .7 mL/mL 10819-6006-01 Professional 3.23 ml — — FDA listed —
Sani Professional Hands Instant Sanitizing Wipes .7 mL/mLthis 10819-6007-01 Professional 484 ml — — FDA listed —
Sani Professional Hands Instant Sanitizing Wipes .7 mL/mL 10819-6008-01 Professional 805.44 ml — — FDA listed —
Signature Select Instant Hand Sanitizer Wipes with Aloe Vera 70 mL/100mL 21130-0068-01 Living 24 patches — — FDA listed —
Jianerkang Sanitizing Wipe .7 mL/mL 34645-0003-01 Jianerkang 1 patch — — FDA listed —
Instant Hand Sanitizer STERILE 70 Ethyl Alcohol .7 mL/mL 34645-0007-01 Jianerkang 1 patch — — FDA listed —
microdot Hand Sanitizing Wipe 70 mL/100mL 52422-0622-06 Cambridge 563.91 ml — — FDA listed —
Spectrum Hand Sanitizer Wipes 70 mL/100mL 53329-0840-32 Medline 20 applicators — — FDA listed —
Procure Products Hand Sanitizing Wipes 70 mL/100mL 55681-0135-02 TWIN 135 patches — — FDA listed —
Total Solutions Hand Sanitizing Wipes 70 g/100g 62819-0448-00 Athea 70 applicators — — FDA listed —
Soft Care Hand Sanitizing Wipes 70 g/100g 64536-1726-06 Diversey, 895 g — — FDA listed —
Instant Hand Sanitizer Wipes 70 mL/100mL 64709-0185-10 Diamond 1 ml — — FDA listed —
Zep Hand Sanitizer Wipes 70 mL 66949-0405-01 Zep 2 swabs — — FDA listed —
Express Wipes Hand Sanitizer 7 g/10g 67858-0645-02 QuestSpecialty 6 canisters — — FDA listed —
Alcohol Disinfecting Wipe 70 mL 68599-5803-04 McKesson 100 packets — — FDA listed —
Hand Sanitizer 70 mL/100mL 70000-0579-01 Cardinal 135 ml — — FDA listed —
Sani Luxe .7 mL/mL 71489-0009-01 Celeste 1.75 ml — — FDA listed —
Signature Care Instant Hand Sanitizizer Wipes 70 g/100g 74149-0112-01 Yiwu 80 pouches — — FDA listed —
Signature Care Instant Hand Sanitizer Wipes 70 g/100g 74149-0113-01 Yiwu 24 pouches — — FDA listed —
Hand Sanitizer Wipes 70 mL/100mL 75214-0501-20 HANUL 134 ml — — FDA listed —
Instant Hand Sanitizizer Wipes 70 g/100g 75262-0201-01 ZheJiang 80 pouches — — Discontinued —
Tazza 70 mL/100mL 76370-0004-00 Tazza 40 applicators — — FDA listed —
Tazza-X Hand Sanitizing Wipes 70 mL/100mL 76370-0008-00 Tazza 180 applicators — — Discontinued —
Tazza-X Extreme Hand Sanitizing Wipes 70 mL/100mL 76370-0010-00 Tazza 50 pouches — — Discontinued —
Singular Wipes 70 mL/100mL 81428-0070-04 SINGULAR 4 ml — — FDA listed —
Singular Wipes lavender fragrance 70 mL/100mL 81428-0072-01 SINGULAR 30 pouches — — FDA listed —
Travel Wipes Moisturizer and fragrance 70 mL/100mL 81428-0074-01 SINGULAR 15 pouches — — FDA listed —
alcohol pad 01 .7 mL 82953-0012-01 Cosmuses 1 cloth — — FDA listed —
Alcohol Cleansing Wipe .7 mL/mL 83165-0001-00 Hubei 1 patch — — FDA listed —
Hand Sanitizing Wipes 70 mL/100mL 83986-0028-64 UpLift 20 packets — — FDA listed —
Zany Antiseptic Gel .7 mL/mL 55715-0004-01 Laboratorios 120 ml — — FDA listed —
Antibacterial Hand Sanitizer .7 mL/mL 63710-0001-01 Laboratorios 500 ml — — FDA listed —
Zeyco Antiseptic Hand Sanitizer Gel .7 mL/mL 63710-0002-01 Laboratorios 125 ml — — FDA listed —
Zeyco Hand Sanitizer .7 mL/mL 63710-0003-01 Laboratorios 500 ml — — FDA listed —
Antiseptic Hand Sanitizer .7 mL/mL 63710-0004-00 Laboratorios 500 ml — — FDA listed —
Hand Sanitizer .7 mL/mL 67326-0005-00 Degasa, 118 ml — — FDA listed —
Protec Hand Sani Gel Antibacterial .7 mL/mL 67326-0006-00 Degasa, 118 ml — — FDA listed —
Degasa Hand Sanitizer Lemon Lime Scent .7 mL/mL 67326-0010-02 Degasa, 59.14 ml — — FDA listed —
Hand Sanitizer .7 mL/mL 70412-0192-36 Zhejiang 236 ml — — FDA listed —
Antibacterial Hand Sanitizer .7 mL/mL 73145-0003-01 ASC 30 ml — — FDA listed —
Antibacterial Hand Sanitizer .7 mL/mL 73145-0004-01 ASC 236 ml — — FDA listed —
AMBI Soothing Hand sanitizer .7 mL/mL 73453-0143-04 AMBI 118 ml — — FDA listed —
Instant Hand Sanitizing Gel .7 mL/mL 77462-0011-01 SORA 50 bottles — — FDA listed —
Instant Sanitizing Gel .7 mL/mL 77462-0012-01 SORA 500 ml — — FDA listed —
XPRO Antiseptic Hand Sanitizer .7 mL/mL 77939-0000-08 Savone 240 ml — — FDA listed —
Cucumber Melon Scented Antibacterial Hand Sanitizer .7 mL/mL 80684-0003-01 Fourstar 29 ml — — FDA listed —
Fresh Peach Scented Antibacterial Hand Sanitizer .7 mL/mL 80684-0004-01 Fourstar 29 ml — — FDA listed —
Ocean Breeze Scented Antibacterial Hand Sanitizer .7 mL/mL 80684-0005-01 Fourstar 29 ml — — FDA listed —
Sweet Pea Scented Antibacterial Hand Sanitizer .7 mL/mL 80684-0006-01 Fourstar 29 ml — — FDA listed —
LEMONBELLA Lavender Hand Sanitizer .7 mL/mL 81319-0112-01 Lemonbella 100.5 ml — — FDA listed —
Reddy Lab Advanced Alcohol Gel Sanitizer .7 mL/mL 79671-0797-10 Flavor 1000 ml — — FDA listed —
CareALL Hand Sanitizer .7 mL/mL 51824-0110-02 New 59 ml — — FDA listed —
Hand-Aid .7 mL/mL 62257-0122-01 ABC 1200 ml — — Discontinued —
Han-I-Size Unscented .7 mL/mL 63533-0645-14 Momar 3785 ml — — FDA listed —
PURELL Advanced Hand Sanitizer E3 Gel .7 mL/mL 21749-0711-89 GOJO 1200 ml — — FDA listed —
Purell Advanced Soothing .7 mL/mL 21749-0713-01 GOJO 30 ml — — Discontinued —
Instant Hand Sanitizer .7 mL/mL 62257-0061-01 ABC 1200 ml — — Discontinued —
PDI Alcohol Prep Pad Sterile Large and Medium .7 mL/mL 10819-3914-01 Professional 200 packets — — FDA listed —
PURELL Advanced Green Certified Instant Hand Sanitizer .7 mL/mL 21749-0702-08 GOJO 237 ml — — Discontinued —
PURELL Professional Advanced Hand Sanitizer Fragrance Free Gel .7 mL/mL 21749-0717-08 GOJO 236 ml — — Discontinued —
Genuine First Aid Hand Sanitizer Ethyl Alcohol .7 mL/mL 50814-0060-01 GFA 60 ml — — FDA listed —
Genuine First Aid Hand Sanitizer with Cap Ethyl Alcohol .7 mL/mL 50814-0061-01 GFA 236 ml — — FDA listed —
Germ Attack Hand Sanitizer .7 mL/mL 66902-0443-02 Natural 60 ml — — FDA listed —
PURELL Advanced Hand Sanitizer be Vibrant .7 mL/mL 21749-0028-01 GOJO 30 ml — — FDA listed —
Genuine First Aid Hand Sanitizer Ethyl Alcohol .7 mL/mL 50814-0063-01 GFA 473 ml — — FDA listed —
North Woods Derma Gel Clear .7 mL/mL 53125-0801-04 Superior 3780 ml — — FDA listed —
Be Smart Get Prepared Hand Sanitizer .7 mL/mL 55550-0611-01 Total 1 ml — — FDA listed —
PURELL Healthcare Advanced Hand Sanitizer Gel .7 mL/mL 21749-0716-01 GOJO 29 ml — — Discontinued —
Genuine First Aid Hand Sanitizer with Pump Ethyl Alcohol .7 mL/mL 50814-0062-01 GFA 236 ml — — FDA listed —
PURELL Advanced Hand Sanitizer be Blissful .7 mL/mL 21749-0029-01 GOJO 30 ml — — FDA listed —
Instant Hand Sanitizer .7 mL/mL 51824-0020-02 New 59 ml — — FDA listed —
PURELL Advanced Hand Sanitizer be Peaceful .7 mL/mL 21749-0027-01 GOJO 30 ml — — FDA listed —
PURELL Advanced Hand Sanitizer Naturals Gel .7 mL/mL 21749-0625-01 GOJO 30 ml — — FDA listed —
Advanced Alcohol Gel Sanitizer .7 mL/mL 65601-0801-04 Betco 3780 ml — — FDA listed —
Tendersant Hand Sanitizer .7 mL/mL 69771-0007-01 Geri-Gentle 118 ml — — FDA listed —
Hand Sanitizer .7 mL/mL 70412-0194-15 Zhejiang 15 ml — — FDA listed —
Plus Brasept Alcocol Gel .7 mL/mL 83318-0605-14 NEWDROP 3785 ml — — Discontinued —
Germ Attack Hand Sanitizer .7 mL/mL 66902-0943-12 Natural 3785 ml — — FDA listed —
PURELL Advanced Hand Sanitizer Green Certified Gel .7 mL/mL 21749-0708-08 GOJO 237 ml — — FDA listed —
Uline Hand Sanitizer .7 mL/mL 69790-0801-04 Uline 3780 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Mar 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.

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

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesaloe barbadensis leaf juice, glycerin, propylene glycol, purified water, tocopheryl acetate

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.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code10819
First marketedMar 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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses To decrease bacteria on the skin

⏱️ Dosage and Administration 82 words ▾

Directions Canister: to dispense, lift cover, remove seal, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep cap closed to prevent moisture loss. use entire wipe to thoroughly wipe hands, fingers, and wrists for dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe discard after single use Packet: open packet use entire wipe to thoroughly wipe hands, fingers, and wrists to sanitize, use multiple wipes discard after single use

⚠️ Warnings 54 words ▾

Warnings For external use only Flammable. Keep away from fire or flame When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not use in or contact with eyes Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

📦 Storage and Handling 12 words ▾

Other information Lot No. and Expiration Date can be found on canister

🧪 Active Ingredient 7 words ▾

Active Ingredient Ethyl Alcohol 70% by volume

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients aloe barbadensis leaf juice, glycerin, propylene glycol, purified water, tocopheryl acetate

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Keep Out of Reach of Children 29 words ▾

Keep out of reach of children Keep out of reach of children unless under adult supervision If swallowed, get medical help or contact a Poison Control Center right away

📄 Package Label / Principal Display Panel 15 words ▾

Principal display panel Packet Canister, 150ct Canister, 300ct packet front back front 300 back 300

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sani Professional Hands Instant Sanitizing Wipes (this brand).

Top reported reactions

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

Age at onset

Neonate26
Infant14
Child16
Adolescent92
Adult2,810
Elderly294

Reporter sex

26,727 reports
Male · 55%
Female · 45%
Unknown · 0%

Serious outcomes

Death15,128
Hospitalization8,618
Life-threatening1,403
Disabling212
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,655 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 FDA registers it as 10819-6007-1, 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: 10819-6007-01, written without dashes as 10819600701. 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 10819-6007-01, the first segment (10819) is the labeler code FDA assigned to Professional Disposables International, Inc.; the middle segment (6007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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.
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.
← 10819-6006-01 · Professional 10819-6008-01 · 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.