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Henry Schein Povidone-Iodine Prep Pad 1 g/100mL Swab, 8000 pouches — NDC 00404-0121-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Henry Schein Povidone-Iodine Prep Pad 1 g/100mL Swab, 8000 pouches — NDC 0404-0121-01 (Billing 00404-0121-01)

by Henry Schein, Inc. · 8000 POUCH in 1 CASE / .5 mL in 1 POUCH

This is a package of 8,000 pouches of Henry Schein Povidone-Iodine Prep Pad 1 g/100mL Swab from Henry Schein, Inc., marketed since Oct 2019 and currently FDA-listed. It is this product's only package size.

NDC 00404-0121-01
🏷️ FDA NDC (as labeled) 0404-0121-01 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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

⚠️
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) 0404-0121-01
Product NDC 0404-0121
11-digit billing NDC 00404012101
RxCUI 797730
UNII 85H0HZU99M
Application # M003
SPL Set ID 313416b8-60b2-4a77-9b56-5c507aae9072
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 2019-10-22
Route TOPICAL
Dosage form SWAB
Substance POVIDONE-IODINE
Quick answers
  • RxCUI (RxNorm): 797730
Why two NDCs? The FDA registers this code as 0404-0121-01 — a 4-4-2 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 labeler segment → 00404-0121-01. 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 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.
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
00404-0121-01 You're viewing this Main listing 8000 POUCH in 1 CASE / .5 mL in 1 POUCH 2019-10-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/100mLthis 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/mL 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 —
PVP-I Prep Pads paper-foil 1 g/100mL 65517-0039-01 Dukal 1 applicator — — FDA listed —
Proheal Povidone Iodine Prep Pads 1 g/100mL 86173-0002-12 Click 120 packets — — FDA listed —
Povidone-Iodine Gel 1 g/100mL 65517-0070-01 Dukal 29.5 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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 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 S38J6RZN16
    Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
  • UNII K7O76887AP
    A synthetic surfactant (detergent-like substance) used as an emulsifier and solubilizer. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII 1C4QK22F9J
    Potassium iodide is an inorganic salt that supplies iodine. In medicines, it acts as a preservative and stabilizer to prevent degradation of active ingredients and extend shelf life.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

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

The official label also statesalkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

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

LabelerHenry Schein, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code00404
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio172 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Use For preparation of the skin prior to surgery

⏱️ Dosage and Administration 11 words ▾

Directions Clean area. Apply to the operative site prior to surgery

⚠️ Warnings 56 words ▾

Warnings For external use only. Do not apply to persons allergic to iodine. Do not use in the eyes. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns. Keep out of reach of children If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active ingredient Povidone Iodine USP 10%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 20 words ▾

Do not use in the eyes. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

📄 Keep Out of Reach of Children 23 words ▾

Keep out of reach of children If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

📄 Other Information 10 words ▾

Other information 1 % titratable iodine. Store at room temperature

📄 Package Label / Principal Display Panel 55 words ▾

Principal Display Panel - 0.5 mL Item Label HENRY SCHEIN ® REF 570-1543 NDC 0404-0121-01 POVIDONE-IODINE PREP PAD 10% Povidone-Iodine For Professional and Hospital Use Re-use is not allowed Not made with natural rubber latex Non-Sterile 1/Pouch Made in China Distributed by: Henry Schein Inc. 135 Duryea Road Melville, NY 11747 USA Rev. 2026/09 570-1543

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 Henry Schein Povidone-Iodine Prep Pad (this brand).

Top reported reactions

Endophthalmitis176
Nausea169
Rash165
Pain158
Drug Hypersensitivity141
Type 2 Diabetes Mellitus129
Pericarditis128

Age at onset

Neonate9
Infant5
Child7
Adolescent3
Adult190
Elderly96

Reporter sex

1,477 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization543
Death294
Life-threatening272
Disabling196
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 193 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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, 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.
← 00404-0120-03 · Henry 00404-0122-02 · Henry →
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.