Theraworx PM Nighttime Maximum Strength Pain Relief

Product NDC: 61594-044
11-digit product format: 615940044
Labeler code: 61594
Product ID: 61594-044_5d4f6c02-183f-001e-e063-6294a90a3b80
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: 2024-09-01
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: 2027-12-31
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 PM Nighttime Maximum Strength Pain Relief
Listing expiration: 2027-12-31

Active Ingredients#

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

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
61594-044-00	Theraworx PM Nighttime Maximum Strength Pain Relief	1 in 1 CARTON	LIQUID	1		2
61594-044-00	Theraworx PM Nighttime Maximum Strength Pain Relief	74 mL in 1 BOTTLE	LIQUID	74		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61594-044-00	ML - Milliliter	61594-044	c0b6419a-4f81-47b1-b6ba-bcde30b73862	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61594-044	THERAWORX PM NIGHTTIME MAXIMUM STRENGTH PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.]	2	Current NDC, 2 package rows	20240921_bc8cb476-9a47-47b3-ad78-a6ecec9ee66f.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 146 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPER BLUE STUFF Pain Relief Cream	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	066a2106-2e25-4df6-9a8d-4417ba190205	2023-11-10	Warnings	Exact identifier application number: M017
INVIGO FLEX Pain Relief Gel	MENTHOL	WYNNPHARM INC.	909e1d8c-c517-4d6a-8682-894f042c00f8	2023-11-10	Warnings	Exact identifier application number: M017
ARNIMAX Penetrating Pain Relief Gel	MENTHOL	WYNNPHARM INC.	3a31f805-19c6-4036-a663-ebef9b212007	2023-11-10	Warnings	Exact identifier application number: M017
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Exact identifier application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVING	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	da004500-5e48-487b-b96f-520a3094096c	2023-11-10	Warnings	Exact identifier application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	MENTHOL, METHYL SALICYLATE	Rexall Sundown, LLC	55c55f1c-d2b3-6363-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
NEUROFLEX Topical Pain Relieving Liquid	CAMPHOR (SYNTHETIC), MENTHOL	Almark Products Inc	6da3aa84-7a01-4041-8792-a4bbf49e6e4e	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR 60-second Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	3b74b542-202f-469e-8025-4372e95e6b01	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f8b8d1-a20b-54b0-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f92e71-fe2e-16f4-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M017
Teeter Renew Muscles Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	b90dc5b9-c31d-4770-a291-98d036ae8723	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR Foot and Leg Rub	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	57094238-506b-48c1-8eb9-fe904be80df0	2023-11-10	Warnings	Exact identifier application number: M017
SKIN A COOL Hydrocortisone Anti-Itch	HYDROCORTISONE	Ana-Cool, LLC	e3ea7406-e494-4038-9b28-8d0a28b4b834	2023-11-10	Warnings	Exact identifier application number: M017
Teeter reNEW MUSCLES Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	ebc777b0-d141-4a62-9366-d14787eaefe0	2023-11-10	Warnings	Exact identifier application number: M017
FEELGOOD LAB Natural Pain Cream	MENTHOL	The Feel Good Lab, LLC	799d464c-aaf1-429a-877b-2a692397bb49	2023-11-10	Warnings	Exact identifier application number: M017
HIGHER CONTROL Male Climax Control Lubricating	BENZOCAINE	Product Max Group Inc	5f5fd127-34c5-403a-aa95-c9874ae79492	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f93076-1f68-58e6-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f9622e-27c7-6a5d-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
FEEL GOOD LAB Natural Pain Cream	MENTHOL	THE FEEL GOOD LAB, LLC	774a72b1-b719-4217-846e-7f9921fd1b16	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Climax Control Gel	BENZOCAINE	PRODUCT MAX GROUP INC	53e746cc-0078-4381-bf0b-9c8f98d66904	2023-11-10	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	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2
1987647	lidocaine hydrochloride 40 MG/ML Topical Solution	SCD	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2
1987647	lidocaine hydrochloride 4 % Topical Solution	SY	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61594-044-00	61594004400	1 BOTTLE in 1 CARTON (61594-044-00) / 74 mL in 1 BOTTLE	1 bottle	2024-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Theraworx PM Nighttime Maximum Strength Pain Relief Roll-On	AVADIM HOLDINGS, INC.	2026-10-08	HUMAN OTC DRUG LABEL	3