lidotral 5 percent roll on gel

Generic: lidocaine hydrochloride

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

Drug Facts

Product Profile

Brand Name lidotral 5 percent roll on gel
Generic Name lidocaine hydrochloride
Labeler puretek corporation
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 50 mg/g

Manufacturer
Puretek Corporation

Identifiers & Regulatory

Product NDC 59088-327
Product ID 59088-327_1c4c9ce5-f12d-9c47-e063-6294a90a0b3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2024-08-02

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 59088327
Hyphenated Format 59088-327

Supplemental Identifiers

RxCUI
1010057
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 5 percent roll on gel (source: ndc)
Generic Name lidocaine hydrochloride (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07)
source: ndc

Packages (1)

59088-327-07 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07)

Ingredients (1)

lidocaine hydrochloride (50 mg/g)

Linked Drug Pages (1)

Lidotral 5 Percent Roll On Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1c4c9ce5-f12d-9c47-e063-6294a90a0b3c", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1010057"], "spl_set_id": ["1c4c9ce5-f12d-9c47-e063-6294a90a0b3c"], "manufacturer_name": ["Puretek Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07)", "package_ndc": "59088-327-07", "marketing_start_date": "20240802"}], "brand_name": "Lidotral 5 Percent Roll On Gel", "product_id": "59088-327_1c4c9ce5-f12d-9c47-e063-6294a90a0b3c", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "59088-327", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Puretek Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidotral 5 Percent Roll On Gel", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "50 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20240802", "listing_expiration_date": "20261231"}