Over-the-counter drug · OTC MONOGRAPH DRUG
Protex Balance antibacterial hand (Benzalkonium chloride) NDC 35000-255
Benzalkonium chloride 1.33 mg/mL · Liquid · Topical · Colgate-Palmolive Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35000-255-75 | 35000025575 | 221 mL in 1 BOTTLE (35000-255-75)Marketed from Oct 17, 2022 |
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)
- Protex Balance antibacterial hand
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 1.33 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Colgate-Palmolive CompanyNDC labeler code 35000
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 35000-255_c14dde58-8910-435b-8bb4-2b7a72cee316SPL ID c14dde58-8910-435b-8bb4-2b7a72cee316SPL set ID d2514b67-303a-40f4-867b-9f41c0c8cba8RxCUI 1046593UNII F5UM2KM3W7UPC 0035000107084
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
N435000025575followed by a unit qualifier and the quantityPackage 35000-0255-75. 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 helps eliminate bacteria on hands
Excerpt only. Read the full label for complete information.
About NDC 35000-255
- What is NDC 35000-255?
- 35000-255 is the product NDC for Protex Balance antibacterial hand, Benzalkonium chloride 1.33 mg/mL liquid, listed with the FDA by Colgate-Palmolive Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Protex Balance antibacterial hand (Benzalkonium chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Colgate-Palmolive Company, NDC labeler code 35000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Protex Balance antibacterial hand?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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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|---|---|---|---|---|
| PIOELLY Arnica Bruise Cream | Arnica montana 7 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-029 |
| FluMisch Minoxidil Foamminoxidil,biotin | Minoxidil 5 g/100mL; Biotin 5 g/100mL | Aerosol, FoamExtracorporeal | Beijing JUNGE Technology Co., Ltd. | 85212-0001 |
| 0.025% Capsaicin Pain relief Patchcapsaicin pain relief patch, capsaicin pain relief strip | Capsaicin .025 g/100g | PatchTopical | Xuzhou Lanting Pharmaceutical Co., Ltd | 85323-005 |
| BodyMed Alcohol Prep Padalcohol prep pad | Isopropyl alcohol 70 mL/100mL | SwabTopical | Boxout, LLC | 82308-001 |
| Senna Timesennosides | Sennosides a and b 8.6 mg/1 | Tablet, CoatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8402 |
| VQ Hydrating Hand Sanitizer Capri Summeralcohol | Alcohol 70 mL/100mL | LiquidTopical | Tychea Co. | 85980-011 |
| Laxative Sennasennosides | Sennosides 8.6 mg/1 | Tablet, CoatedOral | TOPCO ASSOCIATES LLC | 36800-984 |
| Swisherbenzalkonium chloride | Benzalkonium chloride 5 mg/mL | SolutionTopical | Ecolab Inc. | 47593-591 |
| enMotion Antimicrobial with Moisturizers, Fragrance Freebenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | SoapTopical | Georgia-Pacific Consumer Products LP | 54622-703 |
| Sterile Alcohol Prep Pads 01isopropyl alcohol | Isopropyl alcohol .7 mL/mL | SwabTopical | Total Resources International Inc. | 55550-222 |
| Anti Bacterial Hand Gel Pink Gumballalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6654 |
| Anti Bacterial Hand Gel Fresh Rainfallalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6930 |
| Wet Ones Antibacterial Hand Wipes Lavender Scentbenzalkonium chloride | Benzalkonium chloride .13 g/100g | SwabTopical | Edgewell Personal Care Brands LLC | 63354-536 |
| Senna-Sdocusate sodium, sennosides | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | Tablet, Film coatedOral | Granulation Technology, Inc. | 63561-0187 |
| Sani-Surealcohol | Alcohol 600 mL/L | GelTopical | Whisk Products, Inc. | 65585-359 |
| Smart Care ANTIBACTERIAL HAND SANITIZING WIPES LAVENDER SCENTbenzalkonium chloride | Benzalkonium chloride .11 g/100mL | ClothTopical | Ashtel Studios, Inc. | 70108-208 |
| 4% Lidocaine Pain Relief Patchlidocaine pain relief patch | Lidocaine hydrochloride 4 g/100g | PatchTopical | Xuzhou Lanting Pharmaceutical Co., Ltd | 85323-002 |
| B-Pure Moisturizing Hand Sanitizer Pink Berry Pop Scentedalcohol | Alcohol 70 mL/100mL | LiquidTopical | Fourstar Group USA, Inc. | 80684-223 |
| Sipa hand sanitizer with Moisturizersinstant hand sanitizer | Alcohol 75 mL/100mL | LiquidTopical | Tourel (Changsha)Hotel Supplies Co.,Ltd | 83502-002 |
| VQ Hydrating Hand Sanitizer Pistachio Cremealcohol | Alcohol 70 mL/100mL | LiquidTopical | Tychea Co. | 85980-008 |
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