zylotrol

Generic: lidocaine hcl 4%, menthol 1%

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

Drug Facts

Product Profile

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

lidocaine hydrochloride 4 g/100g, menthol, unspecified form 1 g/100g

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-145
Product ID 76420-145_07cebfba-4f3b-882f-e063-6294a90ac460
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-06-12

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420145
Hyphenated Format 76420-145

Supplemental Identifiers

RxCUI
1373137
UNII
V13007Z41A L7T10EIP3A

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 (source: ndc)
Generic Name lidocaine hcl 4%, menthol 1% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100g
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (76420-145-04) / 118.3 g in 1 TUBE
source: ndc

Packages (1)

76420-145-04 1 TUBE in 1 BOX (76420-145-04) / 118.3 g in 1 TUBE

Ingredients (2)

lidocaine hydrochloride (4 g/100g) menthol, unspecified form (1 g/100g)

Linked Drug Pages (1)

Zylotrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "07cebfba-4f3b-882f-e063-6294a90ac460", "openfda": {"unii": ["V13007Z41A", "L7T10EIP3A"], "rxcui": ["1373137"], "spl_set_id": ["e13984ea-73a9-2894-e053-2995a90a8ed6"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (76420-145-04)  / 118.3 g in 1 TUBE", "package_ndc": "76420-145-04", "marketing_start_date": "20220612"}], "brand_name": "Zylotrol", "product_id": "76420-145_07cebfba-4f3b-882f-e063-6294a90ac460", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "76420-145", "generic_name": "Lidocaine HCl 4%, Menthol 1%", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zylotrol", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "4 g/100g"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220612", "listing_expiration_date": "20261231"}