Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Byotrol Hand Sanitizer (Benzalkonium chloride) NDC 63002-002
Benzalkonium chloride 1.3 mg/mL · Liquid · Topical · Advanced Hygienics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63002-002-12 | 6300200021263002000212 | 1250 mL in 1 BOTTLE (63002-002-12)Marketed from Jun 25, 2014 | |
| 63002-002-50 | 6300200025063002000250 | 500 mL in 1 BOTTLE (63002-002-50)Marketed from Jun 25, 2014 | |
| 63002-002-75 | 6300200027563002000275 | 9463 mL in 1 BOTTLE (63002-002-75)Marketed from Apr 1, 2015 | |
| 63002-002-99 | 6300200029963002000299 | 50 mL in 1 BOTTLE (63002-002-99)Marketed from May 2, 2014 |
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)
- Byotrol Hand Sanitizer
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 1.3 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Advanced Hygienics LLCNDC labeler code 63002
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part333A
- Marketing start
- Listing expires
- Identifiers
- Product ID 63002-002_ef6a1c09-8491-4a08-bedc-a67ce00d9e23SPL ID ef6a1c09-8491-4a08-bedc-a67ce00d9e23SPL set ID 09edbc17-c443-4b0d-9c28-c4b8233c4d1aRxCUI 1020365UNII 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
N463002000212followed by a unit qualifier and the quantityPackage 63002-0002-12. 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 bacteria on the skin. Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 63002-002
- What is NDC 63002-002?
- 63002-002 is the product NDC for Byotrol Hand Sanitizer (benzalkonium chloride), Benzalkonium chloride 1.3 mg/mL liquid, listed with the FDA by Advanced Hygienics LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Byotrol Hand Sanitizer (Benzalkonium chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Advanced Hygienics LLC, NDC labeler code 63002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Byotrol 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 part333A
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 |
|---|---|---|---|---|
| Foaming Mousse Anti-Bacterial Hand Sanitizer Cherry Scentedalcohol | Alcohol 62 mL/100mL | Aerosol, FoamTopical | Ganzhou Olivee Cosmetic Co., Ltd. | 56136-021 |
| Antimicrobial Hand Washchloroxylenol | Chloroxylenol 6 mg/1000mL | SoapTopical | Henry Schein, Inc. | 0404-5990 |
| TOUCH Sanitizing Germ Block, Ocean Mist, 1oz (28.35g)benzalkonium chloride | Benzalkonium chloride .13 g/100g | Aerosol, SprayTopical | Relevo, Inc. | 69744-0204 |
| Hand Wipeschlorhexidine digluconate and benzethonium chloride | Chlorhexidine gluconate .1 g/g; Benzethonium chloride .08 g/g | ClothTopical | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 71734-203 |
| Callington Anti-Bacterial Hand Sanitiserbenzalkonium chloride | Benzalkonium chloride .05 g/g | ClothTopical | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 71734-210 |
| CPAP Mask cleaning wipesbenzethonium chloride and benzalkonium chloride | Benzethonium chloride .03 g/g; Benzalkonium chloride .02 g/g | ClothTopical | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 71734-212 |
| Antimicrobial Hand Washchloroxylenol | Chloroxylenol 6 mg/1000mL | SoapTopical | Henry Schein, Inc. | 0404-5987 |
| KONIX Alcohol Antiseptic Hand Rub | Alcohol 70 mL/100mL | SolutionTopical | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS | 73107-105 |
| HydrAphex | Benzalkonium chloride .0013 g/mL | SolutionTopical | Aphex Biocleanse Systems, Inc | 78003-140 |
| Hand Sanitizerbenzalkonium chloride | Benzalkonium chloride 1.3 g/mL | SolutionTopical | Advanced Hygienics LLC | 63002-004 |
| Foaming Mousse Anti-Bacterial Hand Sanitizer Pineapple Scentedalcohol | Alcohol 62 mL/100mL | Aerosol, FoamTopical | Ganzhou Olivee Cosmetic Co., Ltd. | 56136-022 |
| Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit Scentedalcohol | Alcohol 62 mL/100mL | Aerosol, FoamTopical | Ganzhou Olivee Cosmetic Co., Ltd. | 56136-023 |
| CVS Hand Sanitizeralcohol | Alcohol 56 mg/g | SprayTopical | CVS | 69842-557 |
| BZK Towelettebenzalkonium chloride | Benzalkonium chloride 1.33 mg/mL | SwabTopical | Acme United Corporation | 0924-7112 |
| Mistalcohol | Alcohol 62 mL/100mL | SprayTopical | Derma Glove | 70741-003 |
| Mistalcohol | Alcohol 62 mL/100mL | SprayTopical | Derma Glove | 70741-003 |
| Mistalcohol | Alcohol 62 mL/100mL | SprayTopical | Derma Glove | 70741-003 |
| Mistalcohol | Alcohol 62 mL/100mL | SprayTopical | Derma Glove | 70741-003 |
| Handlotion | Alcohol 70 mL/100mL | LotionTopical | Derma Glove | 70741-006 |
| Soft Care Sentrybenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SolutionTopical | Diversey, Inc. | 64536-1948 |
Showing 20 of 39.