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AUVON Pain Relief Roll-on LIDOCAINE 4 g/100mL Solution, 74 mL — NDC 83391-0004-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AUVON Pain Relief Roll-on LIDOCAINE 4 g/100mL Solution, 74 mL — NDC 83391-004-01 (Billing 83391-0004-01)

by SHENZHEN YUWEN E-COMMERCE CO., LTD. · 74 mL in 1 BOTTLE

This is a package of 74 mL of AUVON Pain Relief Roll-on LIDOCAINE 4 g/100mL Solution from SHENZHEN YUWEN E-COMMERCE CO., LTD., marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 83391-0004-01
🏷️ FDA NDC (as labeled) 83391-004-01 billing pads the product segment with a zero
This package
Contains74 mL Pack sizes3 compare ↓
Main listing for product 83391-004 · Also comes in: 74 mL 83391-004-02 2 bottles 83391-004-03
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 83391-004-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83391 labeler · 004 product · 01 package
Package marketed since
Sep 21, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8339100401 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
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) 83391-004-01
Product NDC 83391-004
11-digit billing NDC 83391000401
RxCUI 1987647
UNII V13007Z41A
Application # M017
SPL Set ID 8b30f623-6077-4f2e-8fa4-ce4a298953b5
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-21
Route TOPICAL
Dosage form SOLUTION
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1987647
Why two NDCs? The FDA registers this code as 83391-004-01 — 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 → 83391-0004-01. 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 Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
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
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →
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: 74 mL 2 bottles
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
83391-0004-01 You're viewing this Main listing 74 mL in 1 BOTTLE 2024-09-21 — Active
83391-0004-02 83391-004-02 1 BOTTLE in 1 PACKAGE / 74 mL in 1 BOTTLE 2024-09-21 — Active
83391-0004-03 83391-004-03 2 BOTTLE in 1 PACKAGE / 74 mL in 1 BOTTLE 2024-09-21 — Active

Pack size FAQ

What quantity is in this package?
This package contains 74 mL — 74 ml in 1 bottle.
What NDC number is used to bill for this package of AUVON Pain Relief Roll-on LIDOCAINE 4 g/100mL 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
Walgreens Pain Relieving with Turmeric Analgesic 40 mg/mL 00363-1222-01 Walgreen 1 bottle — — FDA listed —
Walgreens Pain Relieving with Lavender Analgesic 40 mg/mL 00363-1225-01 Walgreen 1 bottle — — FDA listed —
Walgreen Pain Relieving Fragrance Free 4 g/100g 00363-7790-25 WALGREENS 1 bottle — — FDA listed —
TopCare Pain Relief Maximum Strength 4 g/100g 36800-0529-25 TOPCO 1 bottle — — FDA listed —
Aspercreme with Lidocaine No-Mess Applicator 4 g/100mL 41167-0581-00 Chattem, 1 bottle — — FDA listed —
Aspercreme with Lidocaine Essential Oils Rosemary Mint 4 g/100mL 41167-0598-07 Chattem, 1 bottle — — FDA listed —
Aspercreme with lidocaine No-Mess Applicator Two Pack 4 g/100mL 41167-0599-09 Chattem, 2 bottles — — FDA listed —
Icy Hot Lidocaine No-Mess 4 g/100g 41167-1711-00 Chattem, 42.5 g — — FDA listed —
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic 40 mg/mL 41250-0351-01 Meijer 1 cylinder — — FDA listed —
Good Sense Pain Relief Roll On 4 g/100g 50804-0187-02 Geiss, 71 g — — FDA listed —
Dologesic Roll-On 4 g/100mL 54859-0513-02 Llorens 60 ml — — FDA listed —
Theraworx Pain Relief Roll- On- Lidocaine 40 mg/mL 61594-0028-00 AVADIM 1 bottle — — FDA listed —
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics 40 mg/mL 61594-0030-00 AVADIM 74 ml — — FDA listed —
Theraworx PM Nighttime Maximum Strength Pain Relief 40 mg/mL 61594-0044-00 AVADIM 1 bottle — — FDA listed —
Bactine Max Lidocaine Roll-on 2.5oz 4 g/100g 65197-0840-25 WellSpring 1 bottle — — FDA listed —
pain relief roll-on 4 g/100mL 69452-0393-63 Bionpharma 1 bottle — — FDA listed —
Lipoflavonoid Ear Pain Kids Relief Drops 4 g/100mL 69693-0902-04 Clarion 12.4 ml — — FDA listed —
IceQuake Lidocaine Analgesic 4 g/100mL 69822-0430-03 Southern 74 ml — — FDA listed —
Lidocaine Pain Relief Roll-On 4 g/100mL 69842-0029-97 CVS 1 bottle — — FDA listed —
Leader Lidocaine 4 g/100mL 70000-0099-01 CARDINAL 1 bottle — — FDA listed —
Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic 40 mg/mL 79481-0019-01 Meijer 1 cylinder — — FDA listed —
DOCTORS TOUCH Erase The Pain Lidocaine 40 mg/mL 80045-0400-00 DOCTOR'S 90 ml — — FDA listed —
Thera Plus Max Strength Lidocaine Pain Relief Liquid 40 mg/mL 80684-0098-00 Fourstar 74 ml — — FDA listed —
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On 4 g/100g 83324-0226-71 CHAIN 1 bottle — — FDA listed —
AUVON Pain Relief Roll-on 4 g/100mLthis 83391-0004-01 SHENZHEN 74 ml — — FDA listed —
Bactine Max Bandage 4 g/100mL 65197-0830-00 WellSpring 1 bottle — — FDA listed —
Bactine Max 4 g/100mL 65197-0832-03 WellSpring 1 bottle — — 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 4E05O5N49G
    Ceteth-10 phosphate is a synthetic ingredient made by combining a fatty alcohol with phosphate groups. It works as an emulsifier and surfactant to help mix oil and water in liquid formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 2V6E5WN99N
    A lipid compound made from fatty acids, used as an emulsifier and stabilizer in medicines to help mix oil and water-based ingredients and keep them from separating.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer 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.

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

The official label also statesAcrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, AminomethyI Propanol, Cetearyl Alcohol, Ceteth-10 Phosphate,Cyclopentasiloxane, DicetyI Phosphate, Dimethicone,Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, SD Alcohol, Steareth-21, Water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSHENZHEN YUWEN E-COMMERCE CO., LTD.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code83391
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from SHENZHEN YUWEN E-COMMERCE CO., LTD. labeler code 83391

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Use Temporarily relieves minor pain

⏱️ Dosage and Administration 24 words ▾

Directions Apply a thin layer to the affected area every 6 to 8 hours Use no more than three times in a 24-hour period.

⚠️ Warnings 132 words ▾

Warnings Please read all directions and warnings as follows and use only as directed. For external use only Do not use Alone if you are under 12 years of age, please consult a doctor If you are allergic to the listed ingredients If the package arrives damaged or opened. If you are pregnent or breast feeding At the same time as other topical analgesics On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin Discontinue use and consult a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering Keep out of reach of children and pets.

If ingested, get medical help right away.

📦 Storage and Handling 14 words ▾

Storage Store it in a dry place at room temperature between 20-25 C (68-77F)

🧪 Active Ingredient 7 words ▾

Active i ngredient s Lidocaine HCl 4%

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, AminomethyI Propanol, Cetearyl Alcohol, Ceteth-10 Phosphate,Cyclopentasiloxane, DicetyI Phosphate, Dimethicone,Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, SD Alcohol, Steareth-21, Water

🎯 Purpose 4 words ▾

Purpose s Topical Analgestic

📄 Do Not Use 58 words ▾

Do not use Alone if you are under 12 years of age, please consult a doctor If you are allergic to the listed ingredients If the package arrives damaged or opened. If you are pregnent or breast feeding At the same time as other topical analgesics On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin

📄 Stop Use and Ask a Doctor If 41 words ▾

Discontinue use and consult a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

📄 Keep Out of Reach of Children 15 words ▾

Keep out of reach of children and pets. If ingested, get medical help right away.

📄 Package Label / Principal Display Panel 2 words ▾

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 · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ 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 Lidocaine. CMS lists 8 products for this generic; we show the highest-spend one. 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.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 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 AUVON Pain Relief Roll-on (this brand).

Top reported reactions

Pain3,231
Fatigue3,093
Nausea3,067
Headache2,846
Dyspnoea2,231
Pneumonia2,040
Diarrhoea2,005

Age at onset

Neonate144
Infant62
Child364
Adolescent259
Adult4,984
Elderly3,215

Reporter sex

49,519 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,785
Death5,052
Life-threatening4,235
Disabling1,212
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,463 2,317
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 SHENZHEN YUWEN E-COMMERCE CO., LTD.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (83391-0004-02), 2 bottles (83391-0004-03). 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?
SHENZHEN YUWEN E-COMMERCE CO., LTD. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 83391-0003-01 · SHENZHEN 83391-0007-01 · SHENZHEN →
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.