Home › NDC Lookup › Ingredients › Cleansing Wipes › 43116-0047-04
Cleansing Wipes .04 U/100U; .05 U/100U Cloth, 60 us — NDC 43116-0047-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cleansing Wipes .04 U/100U; .05 U/100U Cloth, 60 us — NDC 43116-047-04 (Billing 43116-0047-04)

by Shenzhen Shierjie Biological Engineering Co., LTD · 60 U in 1 BOX

This is a package of 60 us of Cleansing Wipes .04 U/100U; .05 U/100U Cloth from Shenzhen Shierjie Biological Engineering Co., LTD, marketed since Nov 2025 and currently FDA-listed.

NDC 43116-0047-04
🏷️ FDA NDC (as labeled) 43116-047-04 billing pads the product segment with a zero
This package
Contains60 us Pack sizes4 compare ↓
Product page 43116-0047-01 Also comes in: 1 u 43116-047-01 10 us 43116-047-02 30 us 43116-047-03
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 43116-047-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
43116 labeler · 047 product · 04 package
Package marketed since
Nov 18, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4311604704 1
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43116-047-04
Product NDC 43116-047
11-digit billing NDC 43116004704
UNII 4XI6112496, F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID 43d6041f-18d1-b0e3-e063-6294a90a7c79
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-18
Route TOPICAL
Dosage form CLOTH
Substance POLIHEXANIDE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 43116-047-04 — 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 → 43116-0047-04. 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

🧪 What is this product?

This product is a topical cleansing wipe containing polihexanide hydrochloride and benzalkonium chloride, which are antimicrobial agents. These ingredients are commonly found in wound cleansing and antiseptic wipe products and function to reduce bacteria and germs on skin. The cloth form allows for convenient application to the skin surface. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this category of cleansing wipe products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
Try another pack size: 1 u 10 us 30 us
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
43116-0047-01 43116-047-01 Main listing 1 U in 1 POUCH 2025-11-18 — Active
43116-0047-02 43116-047-02 10 U in 1 BOX 2025-11-18 — Active
43116-0047-03 43116-047-03 30 U in 1 BOX 2025-11-18 — Active
43116-0047-04 You're viewing this 60 U in 1 BOX 2025-11-18 — Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 60 us — 60 u in 1 box.
How does this package differ from NDC 43116-0047-01?
Both are Cleansing Wipes .04 U/100U; .05 U/100U Cloth — the drug itself is identical. This page's package is the 60 us one, while NDC 43116-0047-01 is the 1 u package.
What NDC number is used to bill for this package of Cleansing Wipes .04 U/100U; .05 U/100U Cloth?
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cleansing Wipes .04 U/100U; .05 U/100Uthis 43116-0047-04 Shenzhen 60 us — — 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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 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 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.
  • UNII VC855RRT77
    A natural oil extracted from green tea leaves. It is used in medications as a fragrance and flavoring agent to improve taste and aroma.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII VJJ8CDV5LF
    A synthetic fragrance ingredient that adds a green, floral scent to the medicine. It's used to improve the taste or smell of the product and make it more pleasant to take.
  • 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 2C6WXJ9SZW
    A fragrant plant oil extracted from jasmine flowers, used as a flavor and fragrance agent to improve the taste and aroma of 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 227KB7O2KN
    A fragrant oil extracted from sweet violets that adds pleasant scent and taste to medicines. It serves as a flavoring and aromatic agent in formulations.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAqua, Glycerin, Propylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Vera Extract, Citric Acid, Sodium Citrate, Fragrance, Citrus Limon (Lemon) Peel Oil, Camellia Sinensis Leaf Oil, Jasminum Sambac (Jasmine) Flower Oil, Violet Leaf Absolute.

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

LabelerShenzhen Shierjie Biological Engineering Co., LTD
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code43116
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from Shenzhen Shierjie Biological Engineering Co., LT... labeler code 43116

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use Gentle cleansinng for face, neck, and body, help reduce bacteria on skin, stay hygienic

⏱️ Dosage and Administration 38 words ▾

Directions ●Tear open the single packet. ●Gently wipe thoroughly across your forehead, face, neck, and body. ●Do not Flush. Discard after use. No rinsing needed. ●Children under 6 years of age should be surpervised when using this product.

⚠️ Warnings 10 words ▾

Warnings ●For external use only. ●Disposable wipes, one-time use only.

📦 Storage and Handling 21 words ▾

Other information ● Store below 77°F.(25"C) ● Store in a cool, dry and airy place. ● Validity period for 2 years.

🧪 Active Ingredient 9 words ▾

Active Ingredient Benzalkonium Chloride 0.05%. Poly (hexamethylenebiguanide) hydrochloride 0.04%

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients Aqua, Glycerin, Propylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Vera Extract, Citric Acid, Sodium Citrate, Fragrance, Citrus Limon (Lemon) Peel Oil, Camellia Sinensis Leaf Oil, Jasminum Sambac (Jasmine) Flower Oil, Violet Leaf Absolute.

🎯 Purpose 2 words ▾

Purpose Antibacterial

📄 Do Not Use 21 words ▾

Do not use Do not use if you are allergic to any of the ingredients, not suitable for the skin injuries.

📄 When Using This Product 24 words ▾

When Using When using this product, please do not use in or near the eyes. In case of uncomfortable contact, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 15 words ▾

Stop Use Stop use and ask a doctor if irritation or rash appears and lasts.

📄 Keep Out of Reach of Children 25 words ▾

Keep Oot Of Reach Of Children To avoid the risk of chocking and suffocation, keep wipes and plastic bag away from babies, children and pets.

📄 Package Label / Principal Display Panel 7 words ▾

PRINCIPAL DISPLAY PANEL undefined undefined undefined undefined

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 Shenzhen Shierjie Biological Engineering Co., LTD. 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 3 other package presentations of this same product, including 1 u (43116-0047-01), 10 us (43116-0047-02), 30 us (43116-0047-03). 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?
Shenzhen Shierjie Biological Engineering 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.
← 43116-0046-01 · Shenzhen 43116-0048-01 · Shenzhen →
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.