Over-the-counter drug · OTC MONOGRAPH DRUG
Handsoap (Benzalkonium chloride) NDC 36800-535
Benzalkonium chloride 130 mg/100mL · Soap · Topical · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-535-56 | 36800053556 | 1650 mL in 1 BOTTLE, PLASTIC (36800-535-56)Marketed from Aug 12, 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)
- Handsoap
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 130 mg/100mL
- Dosage form
- Soap
- Route
- Topical
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-535_511532ba-27ac-4788-e063-6394a90a0120SPL ID 511532ba-27ac-4788-e063-6394a90a0120SPL set ID e60ff14a-f78d-c9fa-e053-2995a90a7f10RxCUI 1046593UNII 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
N436800053556followed by a unit qualifier and the quantityPackage 36800-0535-56. 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)
Directions . Use only to refill a Liquid Hand Soap pump bottle. . From pump bottle, apply onto wet hands. . Lather and rinse thoroughly.
Excerpt only. Read the full label for complete information.
About NDC 36800-535
- What is NDC 36800-535?
- 36800-535 is the product NDC for Handsoap (benzalkonium chloride), Benzalkonium chloride 130 mg/100mL soap, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Handsoap (Benzalkonium chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Handsoap?
- 3 other product NDCs are listed under this name. See all Handsoap NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Handsoap products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Handsoapbenzalkonium chloride | Benzalkonium chloride 130 mg/100mL | SoapTopical | CVS Pharmacy Inc. | 51316-705 | 51316-0705-0751316-0705-32 |
| Handsoapbenzalkonium chloride | Benzalkonium chloride 130 mg/100mL | SoapTopical | CVS PHARMACY, INC | 51316-706 | 51316-0706-07 |
| Handsoapbenzalkonium chloride | Benzalkonium chloride 130 mg/100mL | SoapTopical | CVS Pharmacy | 51316-703 | 51316-0703-1151316-0703-5051316-0703-56 |
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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