Lidocaine

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Lidocaine
Generic name: LIDOCAINE 4%
Manufacturer: AvKARE
Product type: HUMAN OTC DRUG
SPL set ID: 70aace2f-47b4-e961-e053-2991aa0a6367
SPL ID: 485cea96-1fb0-10cf-e063-6294a90a82e3
Version: 9
Effective date: 2026-01-14
Source export date: 2026-11-06
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:36:08

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Lidocaine	openfda.brand_name
generic name		LIDOCAINE 4%	openfda.generic_name
manufacturer name		AvKARE	openfda.manufacturer_name
ndc	package	42291-399-30	openfda.package_ndc
ndc	product	42291-399	openfda.product_ndc
ndc11	package	42291039930	derived:openfda.package_ndc
rxcui		1421893	openfda.rxcui
spl id		485cea96-1fb0-10cf-e063-6294a90a82e3	id
spl set id		70aace2f-47b4-e961-e053-2991aa0a6367	set_id
unii		98PI200987	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS For external use only. When using this product do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas Stop use and ask doctor if Allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.