BACTINE MAX .13 g/100mL Liquid
by WellSpring Pharmaceutical Corporation · 1 BOTTLE in 1 CARTON (65197-820-80) / 236 mL in 1 BOTTLE
NDC 65197-0820-80
🏷️ FDA NDC (as labeled)
65197-820-80
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 →
🆔 Identity & classification
FDA NDC (as labeled)
65197-820-80
Product NDC
65197-820
11-digit billing NDC
65197082080
NCPDP billing unit
ML — per mL (volume)
UNII
F5UM2KM3W7
Application #
M003
SPL Set ID
39b26c28-93e0-41a9-8018-f73525ebc015
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-04-15
Route
CUTANEOUS
Dosage form
LIQUID
Substance
BENZALKONIUM CHLORIDE
GPI-14
92100020000905
GPI class
Bactine Max Wound Wash
GCN Seq No
007182
GCN
29601
HICL code
004258
Ingredient (HICL)
Benzalkonium Chloride
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
Q5B
Therapeutic class — specific (HIC3)
Topical Preparations,Antibacterials
AHFS code
84:04.16.00
AHFS class
Astringents, Anti-Infective
FDB label name
BACTINE MAX 0.13% SOLUTION
FDB brand name
Bactine Max
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 65197-820-80 — 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 → 65197-0820-80. 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 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.
🏭 Manufacturer & labeler
LabelerWellSpring Pharmaceutical Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedApr 2023
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
Label name BACTINE MAX 0.13% SOLUTION Ingredient Benzalkonium Chloride
🧪 What is this product?
Bactine Max is a topical liquid spray containing benzalkonium chloride, an antiseptic agent. It is commonly applied to the skin as a first-aid rinse and cleansing product. Benzalkonium chloride functions as a antimicrobial that is typically used to help reduce bacteria on minor cuts, scrapes, and wounds. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and use guidelines for its category.
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.
💬 Questions about Bactine Max Wound Wash?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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 YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesaloe barbadensis leaf extract, edetate disodium, PEG-100 Stearate, propylene glycol, purified 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.
💲 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 Advanced Wound Wash 1.3 mg/mL 00363-9656-10 | Walgreens | 1 bottle | — | — | FDA listed | — |
| HUMCO Merthiolate 1.3 mg/mL 00395-8010-92 | Humco | 59 ml | — | — | FDA listed | — |
| Bak 1 750 .1713 g/100mL 12745-0145-01 | Medical | 473 ml | — | — | FDA listed | — |
| Tincture Merthiolate 1.3 mg/mL 24286-1532-07 | DLC | 30 ml | — | — | FDA listed | — |
| Puri-San Plus Instant Hand Sanitizer 1.3 mg/mL 43097-0457-10 | People's | 1000 ml | — | — | Discontinued | — |
| United Airlines .13 g/100mL 52305-0601-25 | Freshorize | 250 ml | — | — | FDA listed | — |
| Alaska Airlines .13 g/100mL 52305-0602-30 | Freshorize | 250 ml | — | — | FDA listed | — |
| El Valle Merthiolate 1.3 mg/mL 55758-0375-02 | Pharmadel | 30 ml | — | — | FDA listed | — |
| safeHands Hand Sanitizer Fragrance Free .13 g/100mL 60867-0150-02 | Safehands | 52 ml | — | — | FDA listed | — |
| safeHands Hand Sanitizer Clean Linen .13 g/100mL 60867-0152-02 | Safehands | 52 ml | — | — | FDA listed | — |
| QS Plus Plus Instant Hand Sanitizer 1.3 mg/mL 62257-0457-10 | ABC | 1000 ml | — | — | Discontinued | — |
| RELEEV Cold Sore Treatment 1.3 mg/mL 63287-0419-01 | Merix | 1 pouch | — | — | FDA listed | — |
| Quality Choice Merthiolate 1.3 mg/mL 63868-0493-02 | Chain | 59 ml | — | — | FDA listed | — |
| Soft Care Instant Hand Sanitizer AF .13 g/100mL 64536-3628-03 | Diversey, | 1300 ml | — | — | FDA listed | — |
| Bactine Max .13 g/100mLthis 65197-0820-80 | WellSpring | 1 bottle | — | — | FDA listed | — |
| Cold Sore Treatment, 24-7 Life by 7-Eleven 1.3 mg/mL 66715-5189-00 | Lil' | 1 bottle | — | — | FDA listed | — |
| Novex Hand Sanitizer 1.3 mg/mL 66902-0037-25 | Natural | 225 ml | — | — | FDA listed | — |
| Chemcor Chemical Foaming Hand Sanitizer .0013 mg/mL 68041-0519-00 | Chemcor | 4 bottles | — | — | FDA listed | — |
| Antimicrobial 1.3 ug/mg 68599-0214-04 | McKesson | 118 mg | — | — | FDA listed | — |
| Zoono Hand Sanitizer .13 g/100mL 69221-0203-11 | Zoono | 50 ml | — | — | FDA listed | — |
| Zoono Alcohol Free Hand Sanitizer .13 g/100mL 69221-0601-11 | Zoono | 50 ml | — | — | FDA listed | — |
| CVS Merthiolate 1.3 mg/mL 69842-0749-92 | CVS | 59 ml | — | — | FDA listed | — |
| ElimiShield Home and Outdoor Moisturizing Hand Sanitizer 1.3 mg/mL 71853-0006-01 | Bryson | 50 ml | — | — | FDA listed | — |
| U Hand Sanitizer Classic .13 g/100mL 72119-0004-01 | BLUE | 100 ml | — | — | FDA listed | — |
| Mercurochrome First Aid Antiseptic 1.3 mg/mL 73635-1223-01 | Germa | 30 ml | — | — | Discontinued | — |
| Merthiolate Tincture First Aid Antiseptic 1.3 mg/mL 73635-1224-01 | Germa | 30 ml | — | — | Discontinued | — |
| tazza HAND SANITIZER .13 g/.1L 76370-0032-00 | Tazza | 3.78 l | — | — | FDA listed | — |
| tazza Alcohol-Free sanitizer .13 g/.1L 76370-0041-00 | Tazza | 1 l | — | — | FDA listed | — |
| Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0001-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0002-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Unscented Hand Sanitizer 1.3 mg/mL 80499-0003-01 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Pumpkin Spice Hand Sanitizer 1.3 mg/mL 80499-0008-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Blueberry Lemonade Hand Sanitizer 1.3 mg/mL 80499-0009-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Leather Oak Hand Sanitizer 1.3 mg/mL 80499-0010-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Mahogany Teakwood Hand Sanitizer 1.3 mg/mL 80499-0011-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Bubble Gum Hand Sanitizer 1.3 mg/mL 80499-0012-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0013-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Unscented Clean Hand Sanitizer 1.3 mg/mL 80499-0014-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Balsam Fir Hand Sanitizer 1.3 mg/mL 80499-0015-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Blueberry Lemonade Hand Sanitizer Car Safe Alcohol-Free 1.3 mg/mL 80499-0017-00 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Vanilla Woods Hand Sanitizer Car Safe Alcohol Free 1.3 mg/mL 80499-0018-00 | USA | 237 ml | — | — | FDA listed | — |
| Hygiene Clean Vanilla Sugar Hand Sanitizer on the go and car safe 1.3 mg/mL 80499-0030-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Luxury Clean hand Sanitizer on the go and car safe 1.3 mg/mL 80499-0031-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Lavender Blossom Hand Sanitizer 1.3 mg/mL 80499-0103-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Lilac Garden Hand Sanitizer 1.3 mg/mL 80499-0104-01 | USA | 50 ml | — | — | FDA listed | — |
| Hygiene Clean Spring Bloom Hand Sanitizer 1.3 mg/mL 80499-0105-01 | USA | 50 ml | — | — | FDA listed | — |
| Purifi Hand Sanitizer .13 g/100mL 80659-0301-01 | Purifi | 250 ml | — | — | FDA listed | — |
| Merthiolate 1.3 mg/mL 82645-0912-92 | Pharma | 59 ml | — | — | FDA listed | — |
| Caseys .13 g/100g 85844-0001-01 | Zhejiang | 15 patches | — | — | 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
🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.
🔬 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 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
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 |
|---|---|---|---|
| 65197-0820-80 You're viewing this | 1 BOTTLE in 1 CARTON (65197-820-80) / 236 mL in 1 BOTTLE | 2023-04-15 | 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 65197-820-80, 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: 65197-0820-80, written without dashes as 65197082080. 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 65197-0820-80, the first segment (65197) is the labeler code FDA assigned to WellSpring Pharmaceutical Corporation; the middle segment (0820) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use First aid to help prevent bacterial contamination or skin infection in minor cuts, scrapes and burns.
⏱️ Dosage and Administration ▾
Directions Clean the affected area, apply a small amount of this product on the area 1 to 3 times daily; may be covered with a sterile bandage (let dry first).
⚠️ Warnings ▾
Warning For external use only. Do not use on or near the eyes. Do not apply to large areas of the body.
Ask a doctor before use if -you have - deep or puncture wounds - animal bites - serious burns. Stop use and ask doctor if - condition persists or get worse - symptoms persist for more than 7 days. For external use only For external use only Do not use Ask a doctor before use if you have Ask a doctor or pharmacist before use if you are When using this product Stop use and ask a doctor if Pregnancy/breast-feeding warning Keep out of reach of children
🧪 Active Ingredient ▾
Active ingredient Benzalkonium Cl 0.13% w/w
🧪 Inactive Ingredients ▾
Inactive ingredients aloe barbadensis leaf extract, edetate disodium, PEG-100 Stearate, propylene glycol, purified water
🎯 Purpose ▾
Purpose First aid antiseptic
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.