zylotrol maximum pain

Generic: lidocaine 4%, menthol 1%

Labeler: asclemed usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name zylotrol maximum pain
Generic Name lidocaine 4%, menthol 1%
Labeler asclemed usa, inc.
Dosage Form PATCH
Routes
TOPICAL
Active Ingredients

lidocaine .12 g/3g, menthol .03 g/3g

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-581
Product ID 76420-581_0831d32f-b4cd-6e8b-e063-6294a90a38b8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2022-12-23

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420581
Hyphenated Format 76420-581

Supplemental Identifiers

RxCUI
1249758
UNII
98PI200987 L7T10EIP3A
NUI
N0000175682 M0000897 N0000175426 N0000175976

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zylotrol maximum pain (source: ndc)
Generic Name lidocaine 4%, menthol 1% (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .12 g/3g
  • .03 g/3g
source: ndc
Packaging
  • 15 PATCH in 1 BOX (76420-581-15) / 3 g in 1 PATCH
source: ndc

Packages (1)

Ingredients (2)

lidocaine (.12 g/3g) menthol (.03 g/3g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "0831d32f-b4cd-6e8b-e063-6294a90a38b8", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987", "L7T10EIP3A"], "rxcui": ["1249758"], "spl_set_id": ["0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 PATCH in 1 BOX (76420-581-15)  / 3 g in 1 PATCH", "package_ndc": "76420-581-15", "marketing_start_date": "20230607"}], "brand_name": "ZYLOTROL MAXIMUM PAIN", "product_id": "76420-581_0831d32f-b4cd-6e8b-e063-6294a90a38b8", "dosage_form": "PATCH", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "76420-581", "generic_name": "lidocaine 4%, menthol 1%", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ZYLOTROL MAXIMUM PAIN", "active_ingredients": [{"name": "LIDOCAINE", "strength": ".12 g/3g"}, {"name": "MENTHOL", "strength": ".03 g/3g"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221223", "listing_expiration_date": "20261231"}