Over-the-counter drug · OTC MONOGRAPH DRUG
Zylotrol Maximum Pain (Lidocaine 4%, menthol 1%) NDC 76420-581
Menthol .03 g/3g; Lidocaine .12 g/3g · Patch · Topical · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-581-15 | 7642005811576420058115 | 15 PATCH in 1 BOX (76420-581-15) / 3 g in 1 PATCHMarketed from Jun 7, 2023 |
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)
- Zylotrol Maximum Pain
- Generic name (nonproprietary)
- lidocaine 4%, menthol 1%
- Dosage form
- Patch
- Route
- Topical
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 76420-581_0831d32f-b4cd-6e8b-e063-6294a90a38b8SPL ID 0831d32f-b4cd-6e8b-e063-6294a90a38b8SPL set ID 0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91ddRxCUI 1249758UNII L7T10EIP3A, 98PI200987
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic
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
N476420058115followed by a unit qualifier and the quantityPackage 76420-0581-15. 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 the temporary relief of pain.
Excerpt only. Read the full label for complete information.
About NDC 76420-581
- What is NDC 76420-581?
- 76420-581 is the product NDC for Zylotrol Maximum Pain, Menthol .03 g/3g; Lidocaine .12 g/3g patch, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zylotrol Maximum Pain (Lidocaine 4%, menthol 1%).
- What is the active ingredient?
- Menthol, Lidocaine.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zylotrol Maximum Pain?
- 1 other product NDC are listed under this name. See all Zylotrol Maximum Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zylotrol Maximum Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zylotrol Maximum Painlidocaine 4%, menthol 1% | Menthol .03 g/3g; Lidocaine .12 g/3g | PatchTopical | Whitestone Products LLC | 81902-104 | 81902-0104-15 |
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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