Dologesic Roll-On

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: Dologesic Roll-On
Generic name: LIDOCAINE HCL
Manufacturer: Llorens Pharmaceutical International Division, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 81546810-85a8-45fe-b9e6-cdd02cc4c080
SPL ID: 47467d33-95dd-c5ae-e063-6294a90a5b84
Version: 9
Effective date: 2025-12-31
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:29:24

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		Dologesic Roll-On	openfda.brand_name
generic name		LIDOCAINE HCL	openfda.generic_name
manufacturer name		Llorens Pharmaceutical International Division, Inc.	openfda.manufacturer_name
ndc	package	54859-513-02	openfda.package_ndc
ndc	product	54859-513	openfda.product_ndc
ndc11	package	54859051302	derived:openfda.package_ndc
rxcui		1987647	openfda.rxcui
spl id		47467d33-95dd-c5ae-e063-6294a90a5b84	id
spl set id		81546810-85a8-45fe-b9e6-cdd02cc4c080	set_id
unii		V13007Z41A	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 use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this label. do not allow contact with eyes do not bandage or apply local heat (such as heating pads) to the area of use. Stop use and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

Reported adverse events (FAERS/openFDA)#

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