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Bactine Max Antibiotic and Lidocaine Max Pain Relief .04 g/g; 500 U/g; 10000 U/g Ointment, 1 tube — NDC 65197-0827-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bactine Max Antibiotic and Lidocaine Max Pain Relief .04 g/g; 500 U/g; 10000 U/g Ointment, 1 tube — NDC 65197-827-05 (Billing 65197-0827-05)

by WellSpring Pharmaceutical Corporation · 1 TUBE in 1 BOX / 14.2 g in 1 TUBE

This is a package of 1 tube of Bactine Max Antibiotic and Lidocaine Max Pain Relief .04 g/g; 500 U/g; 10000 U/g Ointment from WellSpring Pharmaceutical Corporation, marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 65197-0827-05
🏷️ FDA NDC (as labeled) 65197-827-05 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 65197-827-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65197 labeler · 827 product · 05 package
Package marketed since
Jan 15, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6519782705 3
FDA record last changed
Aug 27, 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) 65197-827-05
Product NDC 65197-827
11-digit billing NDC 65197082705
UNII V13007Z41A, 89Y4M234ES, 19371312D4
Application # M017
SPL Set ID 71300df9-6113-4f25-93ca-28ad7e7f79de
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic; Polymyxin-class Antibacterial
Physiologic effect Decreased Cell Wall Synthesis & Repair; Local Anesthesia
Chemical class Amides; Polymyxins
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 OINTMENT
Substance LIDOCAINE HYDROCHLORIDE; BACITRACIN ZINC; POLYMYXIN B SULFATE
Why two NDCs? The FDA registers this code as 65197-827-05 — 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 → 65197-0827-05. 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.

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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65197-0827-05 You're viewing this Main listing 1 TUBE in 1 BOX / 14.2 g in 1 TUBE 2024-01-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bactine Max Antibiotic and Lidocaine Max Pain Relief .04 g/g; 500 U/g; 10000 U/gthis 65197-0827-05 WellSpring 1 tube — — 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
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

What it looks like

Color yellow
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.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerWellSpring Pharmaceutical Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from WellSpring Pharmaceutical Corporation labeler code 65197

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses First aid to help prevent infection in and temporarily relieves pain due to minor cuts scrapes burns

⏱️ Dosage and Administration 45 words ▾

Directions Adults and children 2 years and older: clean affected area apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily. may be covered with a sterile bandage. Children under 2 years: ask a doctor

⚠️ Warnings 119 words ▾

Warnings For external use only Allergy alert do not use If you are allergic to any of the ingredients Do not use in or near the eyes on large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer than 1 week unless directed by a doctor Stop use and ask a doctor if condition lasts or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

📦 Storage and Handling 9 words ▾

Other information Store at controlled room temperature 68º-77ºF (20º-25ºC).

🧪 Active Ingredient 15 words ▾

Active Ingredients (w/w) Lidocaine (40 mg) Bacitracin Zinc (500 units) Polymyxin B Sulfate (10,000 units)

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients Gossypium Herbaceum (Cotton) Seed Oil, Olea Europaea (Olive) Fruit Oil, Petrolatum, Sodium Pyruvate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

🎯 Purpose 9 words ▾

Purpose External analgesic First aid antibiotic First aid antibiotic

📄 Do Not Use 14 words ▾

Do not use in or near the eyes on large areas of the body

📄 Ask a Doctor Before Use If 16 words ▾

Ask a doctor before use if you have deep or puncture wounds animal bites serious burns

📄 When Using This Product 16 words ▾

When using this product do not use longer than 1 week unless directed by a doctor

📄 Stop Use and Ask a Doctor If 36 words ▾

Stop use and ask a doctor if condition lasts or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction occurs

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Questions or Comments 6 words ▾

Questions? Call 1-844-241-5454 or visit Bactine.com

📄 Package Label / Principal Display Panel 86 words ▾

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC #: 65197-827-05 NEW #1 PAIN RELIEVER* #1 ANTIBIOTIC MEDICINE** ANTIBIOTIC + MAX PAIN RELIEF with LIDOCAINE Kills Bacteria Prevents Infection Max Pain Relief NET WT 0.5 oz (14.2 g) NO STING - OINTMENT *Chosen by people that believe it is the most effective pain reliever active ingredient in WellSpring proprietary consumer research **Chosen by people that believe it is the most effective antibiotic active ingredient in WellSpring proprietary consumer research CT82100A - Bactine Max Antibiotic Carton Artwork Bactine Max Antibiotic

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 Bactine Max Antibiotic and Lidocaine Max Pain Relief (this brand).

Top reported reactions

Pain3,167
Fatigue3,038
Nausea3,029
Headache2,802
Dyspnoea2,165
Pneumonia2,001
Diarrhoea1,966

Age at onset

Neonate144
Infant62
Child363
Adolescent258
Adult4,906
Elderly3,132

Reporter sex

48,644 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,524
Death4,963
Life-threatening4,195
Disabling1,187
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,398 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — 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.
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.
← 65197-0820-80 · WellSpring 65197-0830-00 · WellSpring →
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.