lidothol

Generic: lidocaine hcl, menthol

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name lidothol
Generic Name lidocaine hcl, menthol
Labeler advanced rx of tennessee, llc
Dosage Form GEL
Routes
CUTANEOUS
Active Ingredients

lidocaine hydrochloride 4.5 g/100g, menthol 5 g/100g

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0516
Product ID 80425-0516_3467f4f8-72ee-4446-e063-6294a90a80c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2025-05-05

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 804250516
Hyphenated Format 80425-0516

Supplemental Identifiers

RxCUI
2257313
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 lidothol (source: ndc)
Generic Name lidocaine hcl, menthol (source: ndc)
Routes
CUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 4.5 g/100g
  • 5 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (80425-0516-1) / 99.2 g in 1 TUBE
source: ndc

Packages (1)

80425-0516-1 1 TUBE in 1 BOX (80425-0516-1) / 99.2 g in 1 TUBE

Ingredients (2)

lidocaine hydrochloride (4.5 g/100g) menthol (5 g/100g)

Linked Drug Pages (1)

Lidothol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["CUTANEOUS"], "spl_id": "3467f4f8-72ee-4446-e063-6294a90a80c0", "openfda": {"unii": ["V13007Z41A", "L7T10EIP3A"], "rxcui": ["2257313"], "spl_set_id": ["3467f4c7-122c-40df-e063-6394a90ae36e"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (80425-0516-1)  / 99.2 g in 1 TUBE", "package_ndc": "80425-0516-1", "marketing_start_date": "20250505"}], "brand_name": "Lidothol", "product_id": "80425-0516_3467f4f8-72ee-4446-e063-6294a90a80c0", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "80425-0516", "generic_name": "LIDOCAINE HCl, MENTHOL", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidothol", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "4.5 g/100g"}, {"name": "MENTHOL", "strength": "5 g/100g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20250505", "listing_expiration_date": "20261231"}