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 120 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Muscular Balm CAPSAICIN MENTHOL METHYL SALICYLATE Borden Company (Private) Limited ed79f14e-6b3d-4bf2-9c34-d019c1ba2582 2024-11-04 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE A-S Medication Solutions 3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3 2024-11-04 Warnings Exact identifier application number: M017 Walgreens Ice Blue Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Walgreen Company 1c0ee442-ffd2-4f6c-aab2-f70e295378ad 2024-11-04 Warnings Exact identifier application number: M017 Walgreen Cool n Heat Maximum Strength Pain Relieving MENTHOL, UNSPECIFIED FORM Walgreen Company d5c79476-dde8-4a85-8878-bc2ac3a3d70b 2024-11-04 Warnings Exact identifier application number: M017 LIDOCAINE LIDOCAINE STRATUS PHARMACEUTICALS INC 87a4f559-a4f6-4b9f-98de-b55b073a11c6 2024-11-01 Warnings Exact identifier application number: M017 Walgreens Nerve Pain Relieving Topical Analgesic LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM Walgreen Company 83849eca-e02f-4b43-b3a7-b25e987e08a8 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica White CAMPHOR Sanvall Enterprises, Inc 192039a2-aed6-821b-e063-6394a90a7f29 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica Reforzada CAMPHOR Sanvall Enterprises, Inc 1921a4b1-cd36-195e-e063-6294a90a8793 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica Pain Releiving Roll On with Camphor CAMPHOR Sanvall Enterprises, Inc 173db0e2-611f-55b9-e063-6394a90ac987 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Camphor CAMPHOR Sanvall Enterprises, Inc 1921e851-cf83-0bdb-e063-6294a90a357f 2024-10-31 Warnings Exact identifier application number: M017 cortisone HYDROCORTISONE CVS Pharmacy c766deac-d993-4e48-a5c3-4cfde7338dff 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Lavender Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 6c7b39c8-5b65-430a-a529-5b6b14adce18 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Plus Turmeric Analgesic TROLAMINE SALICYLATE Walgreen Company f3a121bc-7572-49a4-9822-2b6d858c19d2 2024-10-31 Warnings Exact identifier application number: M017 dg health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 27dc9e09-fc4f-4b66-a303-177725f3a513 2024-10-31 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC f5419859-3f9f-43ff-9a3f-6aa81af044f0 2024-10-31 Warnings Exact identifier application number: M017 ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM STRATUS PHARMACEUTICALS INC d27fbc17-46b7-4d52-ba29-c99b6c63144a 2024-10-31 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE, MENTHOL R & Y Group, LLC fe0478d8-2f06-cd56-e053-6294a90a58e5 2024-10-30 Warnings Exact identifier application number: M017 JOINT-RITIS PAIN RELIEVING ROLL-ON MENTHOL Lifeline Naturals of America, Inc. ec5d99c4-6bba-45d1-84e0-12fb7cb31495 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Walgreen Company 3215a676-104c-43c3-aa36-b30d5b67799a 2024-10-30 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