lidotral 3.88% roll on

Generic: lidocaine hci

Labeler: puretek corporation
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name lidotral 3.88% roll on
Generic Name lidocaine hci
Labeler puretek corporation
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 38.8 mg/g

Manufacturer
PureTek Corporation

Identifiers & Regulatory

Product NDC 59088-307
Product ID 59088-307_db1085fe-0a1e-c4cc-e053-2a95a90aa838
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2024-02-28

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 59088307
Hyphenated Format 59088-307

Supplemental Identifiers

RxCUI
2675768 2675772
UNII
V13007Z41A

Packaging Origin

Original Packager
true

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 lidotral 3.88% roll on (source: ndc)
Generic Name lidocaine hci (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 38.8 mg/g
source: ndc
Packaging
  • 85 g in 1 BOTTLE (59088-307-07)
source: ndc

Packages (1)

59088-307-07 85 g in 1 BOTTLE (59088-307-07)

Ingredients (1)

lidocaine hydrochloride (38.8 mg/g)

Linked Drug Pages (1)

Lidotral 3.88% Roll on ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "db1085fe-0a1e-c4cc-e053-2a95a90aa838", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["2675768", "2675772"], "spl_set_id": ["db1085fe-0a1f-c4cc-e053-2a95a90aa838"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85 g in 1 BOTTLE (59088-307-07)", "package_ndc": "59088-307-07", "marketing_start_date": "20240228"}], "brand_name": "Lidotral 3.88% Roll on", "product_id": "59088-307_db1085fe-0a1e-c4cc-e053-2a95a90aa838", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "59088-307", "generic_name": "Lidocaine HCI", "labeler_name": "PureTek Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidotral 3.88% Roll on", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "38.8 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20240228", "listing_expiration_date": "20261231"}