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 122 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DG Health Hydrocortisone Maximum Strength HYDROCORTISONE Dolgencorp Inc 2cc792b8-dce6-4178-bd6d-63ba268b7747 2024-10-19 Warnings Exact identifier application number: M017 Careland Hydrogel Pain Relief Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. e970070c-1c3b-49f0-8298-e6c5ebbf50a0 2024-10-18 Warnings Exact identifier application number: M017 Fruit of the Earth Cool Blue Aloe Mist Continuous LIDOCAINE HYDROCHLORIDE Fruit Of The Earth, Inc. d4caae4c-efba-2453-e053-2995a90a5e5f 2024-10-18 Warnings Exact identifier application number: M017 CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving LIDOCAINE HCL CVS Pharmacy f0f1969d-10e0-76ee-e053-2995a90a7336 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wong To Yick Wood Lock Ointment Ltd 16a21af4-6bc0-4ae1-aa3b-1da84c8286e2 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wicsun Trading Inc 0b4bd444-b3c1-47aa-a7e3-f16c92326124 2024-10-17 Warnings Exact identifier application number: M017 Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL LIDOCAINE Fruit of the Earth, Inc. c7a833bd-7457-73a3-e053-2a95a90ac53f 2024-10-17 Warnings Exact identifier application number: M017 Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic LIDOCAINE HYDROCHLORIDE WEGMANS FOOD MARKETS INC f70bc438-7ed8-f74d-e053-6394a90a2b3f 2024-10-16 Warnings Exact identifier application number: M017 EQUATE Sunburn relief with Aloe After Sun LIDOCAINE Wal-Mart Stores Inc c25e1288-7ac6-41fc-ab65-26c379f288a7 2024-10-16 Warnings Exact identifier application number: M017 Genuine First Aid Insect Sting Relief Pad 1 ct BENZOCAINE, ALCOHOL GFA Production (Xiamen) Co., Ltd. b119ba37-0ee1-851a-e053-2995a90a85b1 2024-10-15 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 1a587e6e-88d1-4b01-abad-9a365dc64a4d 2024-10-15 Warnings Exact identifier application number: M017 TopCare Everyday After Sun Cooling LIDOCAINE HYDROCHLORIDE TOPCO ASSOCIATES LLC baff7293-e1a3-d1f2-e053-2995a90a93ca 2024-10-15 Warnings Exact identifier application number: M017 Universal PAIN RELIEF LIDOCAINE Universal Distribution Center LLC b132a4f2-1b1f-4e80-a183-f9add449065f 2024-10-14 Warnings Exact identifier application number: M017 Nervex Pain Relieving CAPSAICIN VITA SCIENCES, LLC a39bba22-8c54-4252-9973-052dd2aaea36 2024-10-14 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain-Relieving LIDOCAINE NATURAL ESSENTIALS, INC. d07fdffd-bf7c-4950-9b2d-c06d54ef4c55 2024-10-14 Warnings Exact identifier application number: M017 Walgreens Cooling LIDOCAINE HYDROCHLORIDE WALGREEN COMPANY baffb272-436c-4ad8-e053-2a95a90a56fb 2024-10-14 Warnings Exact identifier application number: M017 Walgreens Sunburn Relief MENTHOL WALGREEN COMPANY c8967fba-6c28-494b-e053-2995a90acbba 2024-10-14 Warnings Exact identifier application number: M017 Walgreens Sunburn Relief LIDOCAINE WALGREEN COMPANY d5067903-c559-dc6d-e053-2995a90a8ee3 2024-10-14 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF Meijer Distribution Inc 18998e1c-1254-4d0c-93f1-26652c5ca076 2024-10-14 Warnings Exact identifier application number: M017 signature care itch relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Safeway 3eedcd9f-8312-4d14-a0fe-6b00a00d3e73 2024-10-13 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