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POVIDONE-IODINE 10 mg/mL Solution, 100 vials — NDC 46414-7777-2 (Billing 46414-7777-02)

by James Alexander Corporation · 100 VIAL, SINGLE-USE in 1 CONTAINER / .6 mL in 1 VIAL, SINGLE-USE

This is a package of 100 vials of POVIDONE-IODINE 10 mg/mL Solution from James Alexander Corporation, marketed since Feb 1976 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 46414-7777-02
🏷️ FDA NDC (as labeled) 46414-7777-2 billing pads the package segment with a zero
This package
Contains100 vials Pack sizes2 compare ↓
Main listing for product 46414-7777 · Also comes in: 10 vials 46414-7777-3
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 46414-7777-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
46414 labeler · 7777 product · 2 package
Package marketed since
Feb 14, 1976
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4641477772 6
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) 46414-7777-2
Product NDC 46414-7777
11-digit billing NDC 46414777702
RxCUI 312564
UNII 85H0HZU99M
Application # M003
SPL Set ID 181a6363-2249-45f0-a28b-79f2c5ffad59
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 1976-02-14
Route TOPICAL
Dosage form SOLUTION
Substance POVIDONE-IODINE
Quick answers
  • RxCUI (RxNorm): 312564
Why two NDCs? The FDA registers this code as 46414-7777-2 — 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 → 46414-7777-02. 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 mLPer 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: 10 vials
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
46414-7777-02 You're viewing this Main listing 100 VIAL, SINGLE-USE in 1 CONTAINER / .6 mL in 1 VIAL, SINGLE-USE 1976-02-14 — Active
46414-7777-03 46414-7777-3 10 VIAL, SINGLE-USE in 1 CONTAINER / .6 mL in 1 VIAL, SINGLE-USE 1976-02-14 — Active

Pack size FAQ

What quantity is in this package?
This package contains 100 vials — 100 vial, single-use in 1 container / .6 ml in 1 vial, single-use.
How does this package differ from NDC 46414-7777-03?
Both are POVIDONE-IODINE 10 mg/mL Solution — the drug itself is identical. This page's package is the 100 vials one, while NDC 46414-7777-03 is the 10 vials package.
What NDC number is used to bill for this package of POVIDONE-IODINE 10 mg/mL Solution?
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
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/mLthis 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 —
First Aid Antiseptic 10 mg/mL 49035-0050-34 Walmart 237 ml — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-0011-01 Aplicare 30 ml — — Discontinued —
Aplicare Povidone-Iodine 10 mg/mL 52380-4801-08 Aplicare 118 ml — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-1905-00 Aplicare 60 ml — — FDA listed —
Betadine Solution 10 mg/mL 67618-0150-01 Atlantis 3780 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 72476-0050-34 Retail 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 36800-0011-34 Topco 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 55319-0700-26 Family 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 00363-0777-34 Walgreen 236 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 72288-0450-26 Amazon.com 118 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 00924-5408-01 Acme 10 vials — — FDA listed —
Povidone-Iodine 10 mg/mL 37808-0624-34 H 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 11822-9050-01 Rite 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 55910-0001-26 Old 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 41250-0720-34 Meijer, 237 ml — — FDA listed —
Povidone-Iodine Topical Antiseptic 10 mg/mL 53329-0939-04 Medline 118 ml — — FDA listed —
Betadine Solution Swabsticks 10 mg/mL 67618-0153-01 Atlantis 1 applicator — — Discontinued —
Povidone-Iodine 10 mg/mL 50332-0056-01 HART 10 vials — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-2801-08 Aplicare 59 ml — — FDA listed —
Povidone Iodine Solution First Aid Antiseptic 10 mg/mL 11344-0050-26 Nice-Pak 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 21130-0891-34 Better 236 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 11673-0003-34 Target 236.5 ml — — FDA listed —
povidone-iodine 10% 10 mg/mL 69452-0483-93 BIONPHARMA 237 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

🏛️
1976
On the market since
Feb 1976
📍
2026
Currently FDA-listed
50 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerJames Alexander Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code46414
First marketedFeb 1976
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from James Alexander Corporation labeler code 46414

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Uses To treat minor skin cuts and abrasions.

⏱️ Dosage and Administration 26 words ▾

Directions Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

⚠️ Warnings 40 words ▾

Warnings For external use only. Ask a doctor before use if you have • deep or puncture wounds • serious burns Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases • infection occurs.

🧪 Active Ingredient 12 words ▾

Active Ingredients (each swab) 10% Povidone Iodine Solution USP, (1% available Iodine)

🧪 Inactive Ingredients 10 words ▾

Inactive Ingredients Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

🎯 Purpose 3 words ▾

Purpose Topical Antiseptic

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 15 words ▾

Other Information Store at room temperature away from light. Keep from freezing or excessive heat.

📄 Questions or Comments 10 words ▾

Questions? Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t.

📄 Package Label / Principal Display Panel 3 words ▾

Packaging image description

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.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 James Alexander 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 1 other package presentation of this same product, including 10 vials (46414-7777-03). 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?
James Alexander 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.
← 46414-3333-02 · James 46438-0001-01 · Dipharma →
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.