Home NDC 61594-030 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.
DailyMed Product Concepts# 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 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 121 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Pain Relieving Plus Turmeric Analgesic TROLAMINE SALICYLATE Walgreen Company f3a121bc-7572-49a4-9822-2b6d858c19d2 2024-10-31 Warnings Exact identifier application number: M017 dg health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 27dc9e09-fc4f-4b66-a303-177725f3a513 2024-10-31 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC f5419859-3f9f-43ff-9a3f-6aa81af044f0 2024-10-31 Warnings Exact identifier application number: M017 ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM STRATUS PHARMACEUTICALS INC d27fbc17-46b7-4d52-ba29-c99b6c63144a 2024-10-31 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE, MENTHOL R & Y Group, LLC fe0478d8-2f06-cd56-e053-6294a90a58e5 2024-10-30 Warnings Exact identifier application number: M017 JOINT-RITIS PAIN RELIEVING ROLL-ON MENTHOL Lifeline Naturals of America, Inc. ec5d99c4-6bba-45d1-84e0-12fb7cb31495 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Walgreen Company 3215a676-104c-43c3-aa36-b30d5b67799a 2024-10-30 Warnings Exact identifier application number: M017 Ultra-Strength Pain Relief Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM TARGET CORPORATION 159c5a84-bf68-41dd-a2d3-bc2402037244 2024-10-30 Warnings Exact identifier application number: M017 DG Health Cold n Hot Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 8fe13b85-ab74-42f8-a664-d3d2959921ac 2024-10-30 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Care Antiseptic Pain Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC 8ba42864-69bf-455c-98d4-7f4ff94edceb 2024-10-29 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway beefab66-b056-4bf1-b047-0780704ab87e 2024-10-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE H E B 15eb4676-5f6e-4c28-b5b9-4e45412dc37a 2024-10-29 Warnings Exact identifier application number: M017 Rael PAIN RELIEF ROLL-ON Analgesic CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM Rael, Inc. e6c49606-7c13-4dc6-a22d-ba54173ba788 2024-10-28 Warnings Exact identifier application number: M017 Monistat Care Instant Itch Relief BENZOCAINE Insight Pharmaceuticals LLC 4e9dc791-419f-4c79-aed4-760f8c17a5dd 2024-10-25 Warnings Exact identifier application number: M017 ZYLOTROL PAIN RELIEVING LIDOCAINE HCL, MENTHOL Asclemed USA, Inc. 1553351c-aee8-4c40-9548-35cce246bda9 2024-10-25 Warnings Exact identifier application number: M017 Outgro BENZOCAINE Medtech Products Inc. d6be8a1d-aca7-42b1-86da-881d42ffe8d5 2024-10-25 Warnings Exact identifier application number: M017 Monistat Complete Care Instant Itch Relief HYDROCORTISONE Insight Pharmaceuticals LLC a0f40504-6183-4f32-8d17-6586b3f386a6 2024-10-25 Warnings Exact identifier application number: M017 Boil Ease BENZOCAINE Insight Pharmaceuticals LLC bf108934-5e1a-4059-9dcf-008f52a83fab 2024-10-25 Warnings Exact identifier application number: M017 Dermarest Eczema Medicated HYDROCORTISONE Insight Pharmaceuticals LLC 0292ab62-5088-45fa-a056-70c2fcc19ef7 2024-10-25 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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