Theraworx Pain Relief Roll-On with Lidocaine for Diabetics

Product NDC: 61594-030
11-digit product format: 615940030
Labeler code: 61594
Product ID: 61594-030_0e6c3fd5-9049-2b53-e063-6294a90aeae4
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE
Dosage form: LIQUID
Route: TOPICAL
Labeler: AVADIM HOLDINGS, INC.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-01
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 40 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Theraworx Pain Relief Roll-On with Lidocaine for Diabetics
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1987647	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61594-030-00	Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	74 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	74		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61594-030-00	ML - Milliliter	61594-030	4c489e9c-92ae-4b53-a4cf-c2782678655e	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61594-030	THERAWORX PAIN RELIEF ROLL-ON WITH LIDOCAINE FOR DIABETICS (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.]	1	Current NDC, 1 package rows	20240601_e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 117 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYCO Clinic Pain Relief	MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	604a30c9-2306-47a1-bd31-94b63639dd90	2024-11-20	Warnings	Exact identifier application number: M017
MYCO Clinic Pain Relief	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	0b489420-3b5c-43c5-aab4-0e3720acf9ce	2024-11-20	Warnings	Exact identifier application number: M017
MYCO Clinic Pain Relief	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	dd906129-a787-4352-856d-d7a915031a6e	2024-11-20	Warnings	Exact identifier application number: M017
Walgreens Arthritis Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	Walgreens Company	80d3031a-7fa9-4f5b-b85e-c7c6ef314801	2024-11-20	Warnings	Exact identifier application number: M017
Anti-Itch Medicated Maximum Strength	BENZOCAINE AND RESORCINOL	Walgreens Company	7fd86dcb-edef-4d0d-b389-7ecea595fe67	2024-11-20	Warnings	Exact identifier application number: M017
Walgreens Pain Relief	BENZOCAINE	Walgreens Company	7cee7234-32cd-4bf3-8a6c-0882585eec7f	2024-11-20	Warnings	Exact identifier application number: M017
Walgreens Advanced Scar Gel	ADVANCED SCAR GEL	Walgreens Company	2c040475-a124-485c-933e-66b452f5ab46	2024-11-20	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Clinic Pharma	274611ea-7fc2-ba3f-e063-6294a90aa50f	2024-11-19	Warnings	Exact identifier application number: M017
First Aid Only Sting Relief Pad	BENZOCAINE	Acme United Corporation	5087cbbd-1bbe-62ed-e054-00144ff8d46c	2024-11-19	Warnings	Exact identifier application number: M017
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	6bb9a782-2394-4c8c-e053-2991aa0a08d4	2024-11-19	Warnings	Exact identifier application number: M017
First Aid Only Sting Relief	BENZOCAINE	Acme United Corporation	697127d1-c02e-16d2-e053-2a91aa0a39fd	2024-11-19	Warnings	Exact identifier application number: M017
First Aid Only Hydrocortisone 1% Anti-Itch	HYDROCORTISONE	Acme United Corporation	e5597b11-b08e-99e1-e053-2a95a90a15a5	2024-11-19	Warnings	Exact identifier application number: M017
Equate Cold Therapy Pain Relieving Roll-on Analgesic	MENTHOL, UNSPECIFIED FORM	Wal-Mart Stores, Inc.	4115f0ac-e12a-4e59-94f5-a47dcc7f8766	2024-11-18	Warnings	Exact identifier application number: M017
Equate Cold Therapy Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Wal-Mart Stores, Inc.	ac6c2112-8692-4628-97d8-3a5a9f509766	2024-11-18	Warnings	Exact identifier application number: M017
Equate Odor-Free Therapy Arthritis Analgesic	TROLAMINE SALICYLATE	Wal-Mart Stores, Inc.	1d73e7b6-c7f9-4680-b3e3-a954b91e1863	2024-11-18	Warnings	Exact identifier application number: M017
First Aid Only Burn	LIDOCAINE HYDROCHLORIDE	Acme United Corporation	9af39fcd-0a57-26d0-e053-2a95a90a99a0	2024-11-17	Warnings	Exact identifier application number: M017
First Aid Only First Aid/Burn	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Acme United Corporation	caa67a05-bdbd-c380-e053-2995a90a0bf1	2024-11-17	Warnings	Exact identifier application number: M017
Meijer Pain Lidocaine Plus Relieving Analgesic	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	b7385140-3f63-4cbc-b557-de1d29d1ea36	2024-11-15	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	c6b9c4e1-bab8-490d-8c00-c43377ad0857	2024-11-15	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Walgreen Company	1a9b8b4c-3e15-49e6-af91-76ed0dc0829e	2024-11-15	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1987647	lidocaine hydrochloride 4 % Topical Solution	PSN	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	1
1987647	lidocaine hydrochloride 40 MG/ML Topical Solution	SCD	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	1
1987647	lidocaine hydrochloride 4 % Topical Solution	SY	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61594-030-00	61594003000	74 mL in 1 BOTTLE, WITH APPLICATOR (61594-030-00)	74 ml	2024-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	AVADIM HOLDINGS, INC.	2024-01-08	HUMAN OTC DRUG LABEL	1