PUREGEN LABS Maximum Strength 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: PUREGEN LABS Maximum Strength Lidocaine
Generic name: LIDOCAINE
Manufacturer: Advanced Rx LLC
Product type: HUMAN OTC DRUG
SPL set ID: f4f89582-49e6-424a-bea7-0694484a7c99
SPL ID: 15cfdc73-c2f3-528e-e063-6394a90a07ae
Version: 1
Effective date: 2024-04-11
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:12:19

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		M015	openfda.application_number
brand name		PUREGEN LABS Maximum Strength Lidocaine	openfda.brand_name
generic name		LIDOCAINE	openfda.generic_name
manufacturer name		Advanced Rx LLC	openfda.manufacturer_name
ndc	package	80513-813-06	openfda.package_ndc
ndc	product	80513-813	openfda.product_ndc
ndc11	package	80513081306	derived:openfda.package_ndc
rxcui		1366789	openfda.rxcui
spl id		15cfdc73-c2f3-528e-e063-6394a90a07ae	id
spl set id		f4f89582-49e6-424a-bea7-0694484a7c99	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 Do not exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using fingers or any mechanical device or applicator. When using this product If the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Allergy alert Certain persons can develop allergic reactions to ingredients in this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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