Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Bactine Max benzalkonium chloride and lidocaine hydrochloride .13 g/100mL; 4 g/100mL Liquid, 118 mL — NDC 65197-811-14 (Billing 65197-0811-14)
by WellSpring Pharmaceutical Corporation · 118 mL in 1 BOTTLE, PLASTIC
This is a package of 118 mL of Bactine Max benzalkonium chloride and lidocaine hydrochloride .13 g/100mL; 4 g/100mL Liquid from WellSpring Pharmaceutical Corporation, marketed since Jun 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 65197-0811-14
🏷️ FDA NDC (as labeled)
65197-811-14
billing pads the product segment with a zero
This package
Contains118 mL
Pack sizes2 compare ↓
Main listing for product 65197-811 · Also comes in:
148 ml 65197-811-15
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
65197-811-14
Product NDC
65197-811
11-digit billing NDC
65197081114
UNII
F5UM2KM3W7, V13007Z41A
UPC
0365197811151, 0365197811144
Application #
M003
SPL Set ID
28e8a311-20a4-45a1-8d5d-ca42b101c275
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
2018-06-22
Route
TOPICAL
Dosage form
LIQUID
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90859902850940
GPI class
Bactine Max
GCN Seq No
085280
GCN
54724
HICL code
010610
Ingredient (HICL)
Lidocaine Hcl/Benzalkonium Chl
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5H
Therapeutic class — specific (HIC3)
Topical Local Anesthetics
AHFS code
72:00.00.00
AHFS class
Local Anesthetics
FDB label name
BACTINE PAIN-CLEANSE 4%-0.13%
FDB brand name
Bactine Pain Relieving-Cleanse
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 085280
- GCN: 54724
- GPI-14 (Medi-Span): 90859902850940
- HICL (First Databank): 010610
- AHFS class code: 72:00.00.00
- RxCUI (RxNorm): 2047877
Why two NDCs?
The FDA registers this code as 65197-811-14 — 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 → 65197-0811-14. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Quaternary ammonium compounds class.
Drug family (ATC)
Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name BACTINE PAIN-CLEANSE 4%-0.13% Ingredient Lidocaine Hcl/Benzalkonium Chl
🧪 What is this product?
Bactine Max is a topical liquid spray that combines two active ingredients commonly used for minor skin irritation and pain. Benzalkonium chloride is an antimicrobial agent that helps reduce bacteria on the skin surface, while lidocaine hydrochloride is a numbing ingredient that functions to relieve minor pain and itching. This is an over-the-counter monograph product, meaning it is marketed under FDA's established guidelines for this category of topical first-aid products.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about benzalkonium chloride and lidocaine hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
Try another pack size:
148 ml
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 65197-0811-14 You're viewing this Main listing | 118 mL in 1 BOTTLE, PLASTIC | 2021-01-17 | — | Active |
| 65197-0811-15 65197-811-15 | 148 mL in 1 BOTTLE | 2018-06-22 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle, plastic.
How does this package differ from NDC 65197-0811-15?
Both are Bactine Max benzalkonium chloride and lidocaine hydrochloride .13 g/100mL; 4 g/100mL Liquid — the drug itself is identical. This page's package is the 118 mL one, while NDC 65197-0811-15 is the 148 ml package.
What NDC number is used to bill for this package of Bactine Max benzalkonium chloride and lidocaine hydrochloride .13 g/100mL; 4 g/100mL Liquid?
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
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2018
On the market since
Jun 2018
📍
2026
Currently FDA-listed
8 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.
- FDA Orange Book · refreshed Sep 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerWellSpring Pharmaceutical Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedJun 2018
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts scrapes minor burns sunburn minor skin irritations
⏱️ Dosage and Administration ▾
Directions adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) children under 2 years, ask a doctor
⚠️ Warnings ▾
Warnings For external use only Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use in or near the eyes do not apply over large areas of the body or in large quantities do not apply over raw surfaces or blistered areas 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information avoid excessive heat
🧪 Active Ingredient ▾
Active ingredients Purpose Benzalkonium Cl 0.13% w/w First aid antiseptic Lidocaine HCl 4% w/w Pain relieving spray
🧪 Inactive Ingredients ▾
Inactive ingredients edetate disodium, fragrances, propylene glycol, purified water
🎯 Purpose ▾
Active ingredients Purpose Benzalkonium Cl 0.13% w/w First aid antiseptic Lidocaine HCl 4% w/w Pain relieving spray
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 ↗
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) | — 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 WellSpring Pharmaceutical 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 148 ml (65197-0811-15). 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?
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.
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.