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: 5eb6574c-2066-4390-befc-8e5d2dd6ede2
SPL ID: 029f4902-bc3a-4fd9-8b5e-388d8ae9cf61
Version: 2
Effective date: 2025-06-12
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:28

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	58980-826-85	openfda.package_ndc
ndc	package	58980-826-30	openfda.package_ndc
ndc	product	58980-826	openfda.product_ndc
ndc11	package	58980082630	derived:openfda.package_ndc
ndc11	package	58980082685	derived:openfda.package_ndc
rxcui		2049533	openfda.rxcui
spl id		029f4902-bc3a-4fd9-8b5e-388d8ae9cf61	id
spl set id		5eb6574c-2066-4390-befc-8e5d2dd6ede2	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 avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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