Over-the-counter drug · OTC MONOGRAPH DRUG
Hygiene Clean Leather Oak Hand Sanitizer (Benzalkonium chloride) NDC 80499-010
Benzalkonium chloride 1.3 mg/mL · Liquid · Topical · USA Broom LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80499-010-01 | 8049900100180499001001 | 50 mL in 1 BOTTLE (80499-010-01)Marketed from Oct 30, 2020 | |
| 80499-010-02 | 8049900100280499001002 | 24 BOTTLE in 1 BOX (80499-010-02) / 50 mL in 1 BOTTLEMarketed from Oct 30, 2020 |
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)
- Hygiene Clean Leather Oak Hand Sanitizer
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 1.3 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- USA Broom LLCNDC labeler code 80499
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 80499-010_08c08f83-9ca4-cad2-e063-6294a90aa787SPL ID 08c08f83-9ca4-cad2-e063-6294a90aa787SPL set ID b5693dee-c75c-08b5-e053-2995a90a4390RxCUI 1049254UNII F5UM2KM3W7UPC 0850019907070
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
N480499001001followed by a unit qualifier and the quantityPackage 80499-0010-01. 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)
Uses For hand sanitizing to decrease the bacteria on skin. Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 80499-010
- What is NDC 80499-010?
- 80499-010 is the product NDC for Hygiene Clean Leather Oak Hand Sanitizer, Benzalkonium chloride 1.3 mg/mL liquid, listed with the FDA by USA Broom LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hygiene Clean Leather Oak Hand Sanitizer (Benzalkonium chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- USA Broom LLC, NDC labeler code 80499. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hygiene Clean Leather Oak Hand Sanitizer?
- 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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