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BZK Benzalkonium Chloride 1.33 mg/mL Swab, 1.4 mL — NDC 34645-5008-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BZK Benzalkonium Chloride 1.33 mg/mL Swab, 1.4 mL — NDC 34645-5008-3 (Billing 34645-5008-03)

by Jianerkang Medical Co., Ltd · 1.4 mL in 1 POUCH

This is a package of 1.4 mL of BZK Benzalkonium Chloride 1.33 mg/mL Swab from Jianerkang Medical Co., Ltd, marketed since Jan 2006 and currently FDA-listed. It is this product's only package size.

NDC 34645-5008-03
🏷️ FDA NDC (as labeled) 34645-5008-3 billing pads the package segment with a zero
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 34645-5008-3 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
34645 labeler · 5008 product · 3 package
Package marketed since
Jan 1, 2006
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3464550083 1
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzalkonium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0374-2026
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) 34645-5008-3
Product NDC 34645-5008
11-digit billing NDC 34645500803
RxCUI 1043307
UNII F5UM2KM3W7
Application # M003
SPL Set ID d96c6ad2-c7e9-4079-9db2-59d108f284bb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-01-01
Route TOPICAL
Dosage form SWAB
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1043307
Why two NDCs? The FDA registers this code as 34645-5008-3 — a 5-4-1 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 package segment → 34645-5008-03. 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.

Clinical

🧪 What is this product?

This is an over-the-counter topical antiseptic swab containing benzalkonium chloride 1.33 mg/mL. Benzalkonium chloride is a quaternary ammonium compound that functions as an antimicrobial agent, commonly used in topical products to help reduce bacteria on the skin. The swab form delivers the antiseptic directly to a localized area. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this category rather than being individually reviewed.

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 eachPer 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
34645-5008-03 You're viewing this Main listing 1.4 mL in 1 POUCH 2006-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
BZK Towelette 1.33 mg/mL 00924-7112-00 Acme 1.4 ml — — FDA listed —
First Aid Only BZK Antiseptic Towelettes 1.3 mg/mL 00924-7115-00 Acme 1.6 ml — — FDA listed —
Bzk 1.33 mg/mLthis 34645-5008-03 Jianerkang 1.4 ml — — FDA listed —
Medi-First Plus Antiseptic Wipes 1.3 mg/mL 47682-0030-71 Unifirst 20 packets — — FDA listed —
Green Guard Antideptic Wipes 1.3 mg/mL 47682-0055-73 Uniforst 25 packets — — FDA listed —
Medi-First Antiseptic Wipes 1.33 mg/mL 47682-0212-12 Unifirst 10 packets — — FDA listed —
MedPride Sterile .133 g 52410-4150-05 Shield 1000 cloths — — FDA listed —
BZK Cleansing Swabsticks 4 Triple 1.33 mg/g 59050-0263-01 Changzhou 3 packets — — FDA listed —
LIGHTS Swabstick .133 g/100g 61333-0208-01 Lights 3 applicators — — FDA listed —
CliniClean BZK Cleansing Swabsticks 1.33 mg/g 69464-0702-03 HR 6 g — — FDA listed —
Thompson Antiseptic 1.33 mg/mL 73408-0032-71 Thompson 20 packets — — FDA listed —
Thompson Antiseptic 1.3 mg/mL 73408-0034-50 Thompson 50 packets — — 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

🏛️
2006
On the market since
Jan 2006
📍
2026
Currently FDA-listed
20 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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesPurified Water INACTIVE INGREDIENTS:

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

LabelerJianerkang Medical Co., Ltd
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code34645
First marketedJan 2006
Product typeHuman Otc Drug
Portfolio56 products on file

More NDCs from Jianerkang Medical Co., Ltd labeler code 34645

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 🧪 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 16 words ▾

Antiseptic Cleansing of face, hands and body without soap and water, Air dries in seconds. USE:

⏱️ Dosage and Administration 10 words ▾

Tear open packet, unfold and use as a washcloth. DIRECTIONS:

⚠️ Warnings 33 words ▾

DO NOT USE: in the eyes or apply over larger area of the body. STOP USE: if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

🧪 Active Ingredient 6 words ▾

Active Ingredient Benzalkonium Chloride, 0.133% w/v

🧪 Inactive Ingredients 4 words ▾

Purified Water INACTIVE INGREDIENTS:

🎯 Purpose 4 words ▾

Purpose First Aid Antiseptic

📄 Do Not Use 33 words ▾

DO NOT USE: in the eyes or apply over larger area of the body. STOP USE: if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

📄 Stop Use and Ask a Doctor If 19 words ▾

STOP USE: if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

📄 Keep Out of Reach of Children 20 words ▾

If swallowed, get medical help or contact a Poison Control Center right away. CAUTION: Keep out of reach of children.

📄 Package Label / Principal Display Panel 4 words ▾

Package Label Pouch Label

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) ✓ 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 Jianerkang Medical Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jianerkang Medical 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.
← 34645-4190-01 · Jianerkang 34645-5500-01 · Jianerkang →
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.