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 101 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Exact identifier application number: M017 myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol MENTHOL Inspec Solutions LLC d4276749-eeff-28f7-e053-2a95a90a593d 2025-01-31 Warnings Exact identifier application number: M017 MyDerm Bite Relief BENZOCAINE Inspec Solutions LLC. 88615668-16b5-7840-e053-2a95a90a9208 2025-01-31 Warnings Exact identifier application number: M017 Maximum Strength Blue Emu Pain Relief Blu Emu TROLAMINE SALICYLATE Kingsway Pharmaceuticals dba NFI, LLC 5e02b820-e53a-42cb-abdb-2925617c29ca 2025-01-31 Warnings Exact identifier application number: M017 Sunset Novelties Herquake NUMBING LUBRICANT SUNSET INTIMATES GROUP INC 2ceeca3e-9197-9166-e063-6394a90ae908 2025-01-30 Warnings Exact identifier application number: M017 Magsoothium CBD Cooling Roll on Relief MENTHOL Ubu/Elements, Inc. 2cf05dcd-6a44-de08-e063-6394a90aaba0 2025-01-30 Warnings Exact identifier application number: M017 Meijer Vagicaine 20% BENZOCAINE AND 3% RESORCINOL CREAM Meijer, Inc. dac73a07-7569-4788-977a-f10d098da75d 2025-01-30 Warnings Exact identifier application number: M017 ZCort Ultra HYDROCORTISONE ACETATE 1% RxDino, LLC b68f8ada-58e8-e8e4-e053-2a95a90ab02d 2025-01-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relieving Gel-Patch LIDOCAINE 4% Noble OTC LLC 12a3ce63-6fce-0993-e063-6294a90a40d5 2025-01-28 Warnings Exact identifier application number: M017 INTIMALE LIDOCAINE DELAY LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 5ddd7d56-bf51-462b-afcd-944861e49781 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Relax Massage CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0eae24e-09cf-0d2d-e053-2a95a90acedc 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebbc0f-9888-b812-e053-2a95a90a5d3d 2025-01-28 Warnings Exact identifier application number: M017 CBDMEDIC Arthritis Aches and Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec7255-bb36-41cd-e053-2a95a90aeac4 2025-01-28 Warnings Exact identifier application number: M017 CBDMEDIC Back and Neck Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec8fc9-c401-5f23-e053-2995a90acb1c 2025-01-28 Warnings Exact identifier application number: M017 Muscle Therapy METHYL SALICYLATE, CAMPHOR Everlaan Organics Inc 0890a683-9a66-fdbd-e063-6294a90ae526 2025-01-27 Warnings Exact identifier application number: M017 Joint Therapy CAMPHOR Everlaan Organics Inc 08904b77-d6db-8b82-e063-6394a90ace4f 2025-01-27 Warnings Exact identifier application number: M017 Warrior Arthritis Relief TROLAMIN SALICYLATE 10% Derma Care Research Labs, LLC 013f48b9-913f-b283-e063-6394a90abd73 2025-01-27 Warnings Exact identifier application number: M017 DCH Cool and Heat MENTHOL 16% Derma Care Research Labs, LLC ff323282-612c-eaf8-e053-6394a90ab779 2025-01-27 Warnings Exact identifier application number: M017 Gerigentle HYDROCORTISONE GERI-GENTLE CORPORATION 0adfa2f0-9758-5c54-e063-6294a90a461f 2025-01-25 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pain Relieving MENTHOL, CAMPHOR Active and Innovative Inc. 42f1abeb-f6d7-01c3-e054-00144ff88e88 2025-01-23 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