Over-the-counter drug · OTC MONOGRAPH DRUG
Cleansing Wipes NDC 43116-047
Polihexanide hydrochloride .04 U/100U; Benzalkonium chloride .05 U/100U · Cloth · Topical · Shenzhen Shierjie Biological Engineering Co., LTD
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43116-047-01 | 4311600470143116004701 | 1 U in 1 POUCH (43116-047-01)Marketed from Nov 18, 2025 | |
| 43116-047-02 | 4311600470243116004702 | 10 U in 1 BOX (43116-047-02)Marketed from Nov 18, 2025 | |
| 43116-047-03 | 4311600470343116004703 | 30 U in 1 BOX (43116-047-03)Marketed from Nov 18, 2025 | |
| 43116-047-04 | 4311600470443116004704 | 60 U in 1 BOX (43116-047-04)Marketed from Nov 18, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cleansing Wipes
- Generic name (nonproprietary)
- cleansing wipes
- Active ingredients
- Polihexanide hydrochloride — .04 U/100UBenzalkonium chloride — .05 U/100U
- Dosage form
- Cloth
- Route
- Topical
- Labeler
- Shenzhen Shierjie Biological Engineering Co., LTDNDC labeler code 43116
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 43116-047_43d6041f-18d2-b0e3-e063-6294a90a7c79SPL ID 43d6041f-18d2-b0e3-e063-6294a90a7c79SPL set ID 43d6041f-18d1-b0e3-e063-6294a90a7c79UNII 4XI6112496, F5UM2KM3W7
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443116004701followed by a unit qualifier and the quantityPackage 43116-0047-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use Gentle cleansinng for face, neck, and body, help reduce bacteria on skin, stay hygienic
Excerpt only. Read the full label for complete information.
About NDC 43116-047
- What is NDC 43116-047?
- 43116-047 is the product NDC for Cleansing Wipes, Polihexanide hydrochloride .04 U/100U; Benzalkonium chloride .05 U/100U cloth, listed with the FDA by Shenzhen Shierjie Biological Engineering Co., LTD. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cleansing Wipes.
- What is the active ingredient?
- Polihexanide hydrochloride, Benzalkonium chloride.
- Who is the labeler?
- Shenzhen Shierjie Biological Engineering Co., LTD, NDC labeler code 43116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cleansing Wipes?
- 1 other product NDC are listed under this name. See all Cleansing Wipes NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cleansing Wipes products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cleansing Wipessalicylic acid | Salicylic acid 2 g/100mL | SwabTopical | Nextcell Medical | 71613-001 | 71613-0001-01 |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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