Home NDC 61594-028 Theraworx Pain Relief Roll- On- Lidocaine
Product NDC 61594-028
11-digit product format 615940028
Labeler code 61594
Product ID 61594-028_5d4f768e-8acc-1d1c-e063-6394a90ac0ae
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 2024-01-15
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 Pain Relief Roll- On- Lidocaine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61594-028-00 Theraworx Pain Relief Roll- On- Lidocaine 1 in 1 CARTON LIQUID 1 1 61594-028-00 Theraworx Pain Relief Roll- On- Lidocaine 74 mL in 1 BOTTLE LIQUID 74 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61594-028 THERAWORX PAIN RELIEF ROLL- ON- LIDOCAINE (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.] 1 Current NDC, 2 package rows 20240115_b4ce3876-f9e3-43ca-810b-75fbe6f887b6.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 93 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DermaRad Relief LIDOCAINE EMULSION RENU LABORATORIES, LLC d5e11f73-918b-eeac-e053-2995a90a4a83 2025-05-06 Warnings Exact identifier application number: M017 Plantar Fasciitis Pain Relief Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 34838622-b092-afeb-e063-6294a90ae7db 2025-05-06 Warnings Exact identifier application number: M017 Climax Shield Delay BENZOCAINE PRODUCT MAX GROUP INC 9c720cdc-f753-47ce-95ff-3b26e461a0ab 2025-05-05 Warnings Exact identifier application number: M017 PediFix Lidocaine Pain-Relief Patches LIDOCAINE PAIN-RELIEF PATCHES PediFix, Inc 346550b9-d2ba-184e-e063-6394a90a591a 2025-05-05 Warnings Exact identifier application number: M017 Walgreens Stop Itch Gel DIPHENHYDRAMINE HCL Walgreens Co 23586336-8f46-3dcd-e063-6394a90accc9 2025-05-04 Warnings Exact identifier application number: M017 WaxRx EarAcheRx Pain Relieving Drops 4% LIDOCAINE HCL DOCTOR EASY MEDICAL PRODUCTS, LLC 34156655-8706-f0a4-e063-6294a90acc90 2025-05-01 Warnings Exact identifier application number: M017 foster and thrive anti itch cream DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Strategic Sourcing Services LLC bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 2025-04-30 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Solis Pharmaceuticals Inc. 3061d301-2104-b1b2-e063-6394a90a9b6e 2025-04-29 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 33ed754e-8852-d5b2-e063-6394a90a7cf2 2025-04-29 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL InterMed Laboratories Private Limited 33ee6e48-243e-4ded-e063-6394a90a987d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 32b96689-8e9b-4c2e-e063-6294a90a7d1c 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Exact identifier application number: M017 Ivarest Poison Ivy Removal and Itch Relief PRAMOXINE HYDROCHLORIDE Blistex Inc. dedbf5d9-0f86-4f32-8321-da86c9838c0a 2025-04-29 Warnings Exact identifier application number: M017 HealthWise 2X Medicated Pain Relief Cream Roll-on MENTHOL Veridian Healthcare 33dae8a8-4197-f276-e063-6294a90aea83 2025-04-28 Warnings Exact identifier application number: M017 HealthWise Roll-on Menthol Pain Relief Gel MENTHOL Veridian Healthcare 33dbb939-9397-7e70-e063-6294a90ac8f4 2025-04-28 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. fa1a98bc-c233-410d-a20e-71111c897372 2025-04-28 Warnings Exact identifier application number: M017 Lidocaine Patch 4% LIDOCAINE 4% Medcore LLC b961906c-fe66-466b-af2c-072781fa098b 2025-04-28 Warnings Exact identifier application number: M017 Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 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 61594-028-00 61594002800 1 BOTTLE in 1 CARTON (61594-028-00) / 74 mL in 1 BOTTLE 1 bottle 2024-01-15 No No Current