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 100 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Medicated Pain Relief Patch LIDOCAINE Safeway, Inc. 2165a342-5f8b-78e0-e063-6394a90a06c4 2025-02-12 Warnings Exact identifier application number: M017 CheeZheng Pain Relieveing Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd. abcebdf1-9037-4094-93e1-ce8f20b18ea7 2025-02-11 Warnings Exact identifier application number: M017 Tibetree Pain Relieveing Medicated Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 4216bd48-5c62-4e87-adcc-67bf7152d64d 2025-02-11 Warnings Exact identifier application number: M017 AsperFlex LIDOCAINE Akron Pharma Inc. ab50525e-b534-452b-8c25-2992c0cbf862 2025-02-10 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Olakino Therapeutics LLC 2a41a621-c6f7-5819-e063-6394a90ae67d 2025-02-07 Warnings Exact identifier application number: M017 Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 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