Over-the-counter drug · OTC MONOGRAPH DRUG
AFFEX Foaming Antimicrobial Hand So ap (Chloroxylenol) NDC 54057-083
Chloroxylenol .003 mg/mL · Liquid · Topical · Afflink, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54057-083-42 | 5405700834254057008342 | 1250 mL in 1 PACKAGE (54057-083-42)Marketed from Nov 15, 2013 |
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)
- AFFEX Foaming Antimicrobial Hand So ap
- Generic name (nonproprietary)
- chloroxylenol
- Active ingredients
- Chloroxylenol — .003 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Afflink, Inc.NDC labeler code 54057
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 54057-083_297b2a97-abd1-a1c4-e063-6394a90ab946SPL ID 297b2a97-abd1-a1c4-e063-6394a90ab946SPL set ID d97c8bb5-78a7-44e0-b68d-890b00f171d8UNII 0F32U78V2Q
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
N454057008342followed by a unit qualifier and the quantityPackage 54057-0083-42. 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 Handwash to help decrease bacteria on the skin Recommended for repeated use
Excerpt only. Read the full label for complete information.
About NDC 54057-083
- What is NDC 54057-083?
- 54057-083 is the product NDC for AFFEX Foaming Antimicrobial Hand So ap, Chloroxylenol .003 mg/mL liquid, listed with the FDA by Afflink, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- AFFEX Foaming Antimicrobial Hand So ap (Chloroxylenol).
- What is the active ingredient?
- Chloroxylenol.
- Who is the labeler?
- Afflink, Inc., NDC labeler code 54057. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for AFFEX Foaming Antimicrobial Hand So ap?
- 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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