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
Manufacturer: STRATUS PHARMACEUTICALS INC
Product type: HUMAN OTC DRUG
SPL set ID: 87a4f559-a4f6-4b9f-98de-b55b073a11c6
SPL ID: 4b196450-e9de-4c85-8652-42d926d951d5
Version: 5
Effective date: 2024-11-01
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:29

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 · 13 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	openfda.generic_name
manufacturer name		STRATUS PHARMACEUTICALS INC	openfda.manufacturer_name
ndc	package	58980-823-30	openfda.package_ndc
ndc	package	58980-823-05	openfda.package_ndc
ndc	product	58980-823	openfda.product_ndc
ndc11	package	58980082330	derived:openfda.package_ndc
ndc11	package	58980082305	derived:openfda.package_ndc
rxcui		1534792	openfda.rxcui
spl id		4b196450-e9de-4c85-8652-42d926d951d5	id
spl set id		87a4f559-a4f6-4b9f-98de-b55b073a11c6	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 "Methemoglobinemia Warning" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use. Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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