Theraworx Pain Relief Roll- On- 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: Theraworx Pain Relief Roll- On- Lidocaine
Generic name: LIDOCAINE HYDROCHLORIDE
Manufacturer: AVADIM HOLDINGS, INC.
Product type: HUMAN OTC DRUG
SPL set ID: b4ce3876-f9e3-43ca-810b-75fbe6f887b6
SPL ID: 08645940-ca97-3f2b-e063-6394a90a386f
Version: 1
Effective date: 2023-10-23
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 06:24:08

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		Theraworx Pain Relief Roll- On- Lidocaine	openfda.brand_name
generic name		LIDOCAINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		AVADIM HOLDINGS, INC.	openfda.manufacturer_name
ndc	package	61594-028-00	openfda.package_ndc
ndc	product	61594-028	openfda.product_ndc
ndc11	package	61594002800	derived:openfda.package_ndc
rxcui		1987647	openfda.rxcui
spl id		08645940-ca97-3f2b-e063-6394a90a386f	id
spl set id		b4ce3876-f9e3-43ca-810b-75fbe6f887b6	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 in large quantities, particularly over raw surfaces or blistered areas When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days 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.