Bactine Max Lidocaine Roll-on 2.5oz 4 g/100g Liquid
by WellSpring Pharmaceutical Corporation · 1 BOTTLE, PLASTIC in 1 BOX (65197-840-25) / 71 g in 1 BOTTLE, PLASTIC
NDC 65197-0840-25
🏷️ FDA NDC (as labeled)
65197-840-25
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
65197-840-25
Product NDC
65197-840
11-digit billing NDC
65197084025
RxCUI
1987647
UNII
V13007Z41A
Application #
M017
SPL Set ID
09b32a98-9131-451e-87a6-81a1e4ed7ec5
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
2024-01-15
Route
TOPICAL
Dosage form
LIQUID
Substance
LIDOCAINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 65197-840-25 — 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 → 65197-0840-25. 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.
🏭 Manufacturer & labeler
LabelerWellSpring Pharmaceutical Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio30 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
- Can I use a lidocaine patch and a lidocaine cream at the same time?
- No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
- Can I put a heating pad on the area where I applied a lidocaine patch?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lidocaine — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Lidocaine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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 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 statesaloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, 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.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| 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/100gthis 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/100mL 83391-0004-01 | SHENZHEN | 74 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
🏛️
2024
On the market since
Jan 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.
📊 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 Bactine Max Lidocaine Roll-on 2.5oz (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65197-0840-25 You're viewing this | 1 BOTTLE, PLASTIC in 1 BOX (65197-840-25) / 71 g in 1 BOTTLE, PLASTIC | 2024-01-15 | Active |
🧭 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 65197-840-25, 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: 65197-0840-25, written without dashes as 65197084025. 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 65197-0840-25, the first segment (65197) is the labeler code FDA assigned to WellSpring Pharmaceutical Corporation; the middle segment (0840) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) 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 WellSpring Pharmaceutical Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WellSpring Pharmaceutical Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily relieves minor pain
⏱️ Dosage and Administration ▾
Directions adults and children 2 years of age and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children 12 years or younger: ask a doctor children under 2 years of age: do not use
⚠️ Warnings ▾
Warnings For external use only Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage or apply local heat (such as heating pads) to area of use Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days, or clear up and occur again within a few days Flammable keep away from fire or flame If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Store at room temperature
🧪 Active Ingredient ▾
Active Ingredients (w/w) Lidocaine HCl 4%
🧪 Inactive Ingredients ▾
Inactive ingredients aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.
🎯 Purpose ▾
Purpose Topical anesthetic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.