Over-the-counter drug · OTC MONOGRAPH DRUG
Cleanse (Benzalkonium chloride 0.13%) NDC 53329-177
Benzalkonium chloride .13 g/100mL · Solution · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-177-04 | 5332901770453329017704 | 118 mL in 1 BOTTLE, PLASTIC (53329-177-04)Marketed from Aug 19, 2016 | |
| 53329-177-06 | 5332901770653329017706 | 473 mL in 1 BOTTLE, PLASTIC (53329-177-06)Marketed from Aug 19, 2016 | |
| 53329-177-08 | 5332901770853329017708 | 221 mL in 1 BOTTLE, PLASTIC (53329-177-08)Marketed from Aug 19, 2016 | |
| 53329-177-25 | 5332901772553329017725 | 3790 mL in 1 BOTTLE, PLASTIC (53329-177-25)Marketed from Aug 19, 2016 | |
| 53329-177-74 | 5332901777453329017774 | 1200 mL in 1 BOTTLE (53329-177-74)Marketed from Aug 1, 2023 | |
| 53329-177-84 | 5332901778453329017784 | 1000 mL in 1 BOTTLE, PUMP (53329-177-84)Marketed from Aug 19, 2016 |
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)
- Cleanse
- Generic name (nonproprietary)
- benzalkonium chloride 0.13%
- Active ingredients
- Benzalkonium chloride — .13 g/100mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53329-177_4a8e1b1c-c742-35f9-e063-6294a90af7deSPL ID 4a8e1b1c-c742-35f9-e063-6294a90af7deSPL set ID 3c56b4c2-42f5-66d7-e054-00144ff8d46cRxCUI 1046593UNII F5UM2KM3W7UPC 0193489179760
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
N453329017704followed by a unit qualifier and the quantityPackage 53329-0177-04. 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 for handwashing to decrease bacteria on the skin
Excerpt only. Read the full label for complete information.
About NDC 53329-177
- What is NDC 53329-177?
- 53329-177 is the product NDC for Cleanse (benzalkonium chloride 0.13%), Benzalkonium chloride .13 g/100mL solution, listed with the FDA by Medline Industries, LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cleanse (Benzalkonium Chloride 0.13%).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cleanse?
- 1 other product NDC are listed under this name. See all Cleanse NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cleanse products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cleansebenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SolutionTopical | Medline Industries, LP | 53329-184 | 53329-0184-0853329-0184-7453329-0184-84 |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizeralcohol | Alcohol 70 mL/100mL | SprayTopical | Church & Dwight Co., Inc. | 10237-117 |
| DrugStore Antibacterial Hand Wipesbenzalkonium chloride | Benzalkonium chloride .13 g/100g | ClothTopical | Lil' Drug Store Products, Inc. | 29485-6666 |
| Ecolabalcohol | Alcohol 62 mL/100mL | SolutionTopical | Ecolab Inc. | 47593-472 |
| Covex Antibacterial Bar Fresh Protectionbenzalkonium chloride | Benzalkonium chloride 1.3 mg/g | SoapTopical | DALAN KIMYA ENDUSTRI ANONIM SIRKETI | 51209-020 |
| Anti Bacterial Hand Gel Cookie Butter Trufflealcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6759 |
| Anti Bacterial Hand Gel Strawberry Kiwialcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-7020 |
| Hyvee LHSbwenzalkonium chloride | Benzalkonium chloride 130 mg/100mL | LiquidTopical | Apollo Health and Beauty Care | 63148-326 |
| Benzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | LiquidTopical | Pharmacy Value Alliance, LLC | 68016-866 |
| Lavender ALOE HAND SANITIZERalcohol | Alcohol .62 mL/mL | GelTopical | K7 Design Group Inc. | 74177-025 |
| hair treatmentminoxidil | Minoxidil 1 mg/473mL | CreamTopical | LABORATORIO MK SRL | 87022-009 |
| SoftSoap Antibacterial with moisturizers Fresh Citrusbenzalkonium chloride | Benzalkonium chloride 1.33 mg/mL | LiquidTopical | Colgate-Palmolive Company | 35000-087 |
| MediChoice PVP Prep Solutionpovidone-iodine | Povidone-iodine 100 mg/mL | SolutionTopical | O&M HALYARD, INC. | 39892-0841 |
| Tartar control pluseucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | United Natural Foods, Inc. dba UNFI | 41163-855 |
| Covex Antibacterial Bar Active Protectionbenzalkonium chloride | Benzalkonium chloride 1.3 mg/g | SoapTopical | DALAN KIMYA ENDUSTRI ANONIM SIRKETI | 51209-017 |
| everyone hand sanitizer wipes ruby grapefruitethyl alcohol | Alcohol 62 mL/100mL | ClothTopical | EO Products, LLC | 54748-703 |
| Povidone-Iodine Prep Sterilepovidone-iodine | Povidone-iodine 100 mg/g | SpongeTopical | Changzhou Maokang Medical Products Co., Ltd | 59050-658 |
| Anti Bacterial Hand Gel Bright Christmas Morningalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6758 |
| Iced Lemon Pound Cake Pistachio Milk and Honeyalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-7018 |
| Hy-Vee LHSbenzalkonium chloride | Benzalkonium chloride 130 mg/100mL | LiquidTopical | Apollo Health and Beauty Care | 63148-316 |
| Smart Care 2 HAND SANITIZERS 1.35 FL OZ (PUMPKIN SPICE, FRESH RAIN)ethyl alcohol | — | Kit | Ashtel Studios, Inc. | 70108-372 |
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