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 110 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dollar General Cold-Hot Medicated Patches MENTHOL DOLGENCORP, LLC c6e0388b-af9e-4e51-8f94-6788185c31a0 2024-12-18 Warnings Exact identifier application number: M017 THERA CARE PAIN THERAPY LIDOCAINE Veridian Healthcare e023bb5a-a4bc-4681-a1f4-48ca0d2cb102 2024-12-18 Warnings Exact identifier application number: M017 TheraCare Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Veridian Healthcare f6f3c9c0-d6e3-75a3-e053-6294a90a1965 2024-12-18 Warnings Exact identifier application number: M017 Good Sense Hot and Cold Medicated Patch MENTHOL GOOD SENSE 1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e 2024-12-18 Warnings Exact identifier application number: M017 Hunter Beach 4% LIDOCAINE HUNTERS BEACH LIFE f2ef9c12-6e42-486b-b6f2-0ad534e94294 2024-12-18 Warnings Exact identifier application number: M017 Hunter Beach 4% LIDOCAINE HUNTERS BEACH LIFE 05a9605b-0d01-4333-8e54-7202e7c31c49 2024-12-18 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE The Mentholatum Company 32b64985-0e2f-49ee-9840-946d7279fee7 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Cold and Hot Pain Relieving Extra Strength MENTHOL, METHYL SALICYLATE CVS Pharmacy 1ca1a631-cb2c-46cd-bd41-05469b08d208 2024-12-17 Warnings Exact identifier application number: M017 Mentholatum Pain Relieving MENTHOL, METHYL SALICYLATE The Mentholatum Company 0056b952-9870-485a-9f35-f985472875a9 2024-12-17 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Heat LIDOCAINE HCL The Mentholatum Company cc2ef25a-b569-4d48-a666-899f710b4b34 2024-12-17 Warnings Exact identifier application number: M017 Rite Aid Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE Rite Aid Corporation 039fff40-b5ba-42cb-932c-8a70ca92759d 2024-12-17 Warnings Exact identifier application number: M017 Signature Care Cold and Hot Medicated MENTHOL Safeway 88f59f95-0a7c-458c-949c-0dff16ad94e4 2024-12-17 Warnings Exact identifier application number: M017 Equate Cool and Heat MENTHOL, METHYL SALICYLATE Wal-Mart Stores Inc c5ab2426-eeca-4ba4-9f00-7790d2176471 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a 2024-12-17 Warnings Exact identifier application number: M017 DG Health Maximum Strength Pain Relieving Cleansing BENZALKONIUM CL, LIDOCAINE HCL Dollar General Corporation 64f69315-77a3-49dc-940d-efd7a29c6645 2024-12-17 Warnings Exact identifier application number: M017 Chiggerex BENZOCAINE RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH 5e5d84ab-f57f-448d-a4c1-ced38890eec2 2024-12-17 Warnings Exact identifier application number: M017 DerMend Moisturizing Anti-Itch PRAMOXINE HYDROCHLORIDE Ferndale Laboratories, Inc. 14c7fb1c-a310-4b12-ab2e-7f1c0801995c 2024-12-17 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Geri-Care Pharmaceuticals, Corp fd67566a-1076-019d-e053-6394a90a415c 2024-12-17 Warnings Exact identifier application number: M017 Extra Strength MENTHOL AND METHYL SALICYLATE NATURES FORMULAE HEALTH PRODUCTS LTD. d919b50a-5de2-1830-e053-2a95a90ab88d 2024-12-17 Warnings Exact identifier application number: M017 Cold and Heat Lidocaine Patch Plus Menthol LIDOCAINE, MENTHOL Walgreen Company 1f262473-3f3c-4f3f-b507-590d06ff69a9 2024-12-17 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