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 125 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DermacinRx Penetral Cream CAPSAICIN PureTek Corporation 1e343a52-6071-3230-e054-00144ff8d46c 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Aromatic CAMPHOR MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 36abfc2c-d424-4df8-968d-866342c96a56 2024-10-02 Warnings Exact identifier application number: M017 Eagle Balm CAMPHOR MENTHOL Eagle Indo Pharma, PT 87614869-9675-2c76-e053-2a95a90a48a9 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited d9a93daa-4e24-6690-e053-2a95a90a147c 2024-10-02 Warnings Exact identifier application number: M017 Eagle Extra Strength MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Oil Refreshing MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited c62a4313-2c07-5f58-e053-2995a90a083a 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Aromatic CAMPHOR MENTHOL METHYL SALICYLATE Eagle Indo Pharma, PT e272ec90-3cd9-5b70-e053-2a95a90a1df4 2024-10-02 Warnings Exact identifier application number: M017 RUGBY HYDROCORTISONE WITH ALOE HYDROCORTISONE A-S Medication Solutions b2674075-aaa4-4c77-bcaa-a76336b3c321 2024-10-02 Warnings Exact identifier application number: M017 Herb Street Anti-Itch Stick HYDROCORTISONE Balassa Laboratories Inc. 8717faae-59c3-4c6f-9ef1-285c0d2445ed 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Backache and Sore Muscle Relief MENTHOL Balassa Laboratories Inc. aeac1b64-8689-4b3d-a41c-db41061257b5 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Arthritis Relief MENTHOL/CAMPHOR Balassa Laboratories Inc. a9d8ceb7-def0-415f-8fc1-ff8dd3e41855 2024-10-01 Warnings Exact identifier application number: M017 Lido King Lidocaine 4% Pain Relieving Gel-Patch LIDOCAINE Galaxy Bio, Inc. 2243734a-4ea2-a5e5-e063-6294a90aba15 2024-10-01 Warnings Exact identifier application number: M017 Medicated Herbal Lip Balm MENTHOL Earth Mama Angel Baby LLC 1cc2391e-6a7a-609c-e063-6394a90a6305 2024-10-01 Warnings Exact identifier application number: M017 CVS Health Lidocaine Plus Pain Relieving LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL NATURAL ESSENTIALS, INC. 1adb9b74-4a01-4461-b845-f3aedcb3f810 2024-10-01 Warnings Exact identifier application number: M017 Circata CAPSAICIN PureTek Corporation b67161d7-cc5c-e971-e053-2995a90acbe7 2024-10-01 Warnings Exact identifier application number: M017 Menticam CAMPHOR,MENTHOL, METHYL SALICYLATE PureTek Corporation ffea2e97-777f-434b-e053-6394a90a3a63 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Sore Muscle Relief METHYL SALICYLATE Balassa Laboratories Inc. e43943c2-d4cd-44c5-a0ff-403a8d42860f 2024-10-01 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Kroger Company 68dab606-0385-48b7-9a7b-a2cf83d20393 2024-09-29 Warnings Exact identifier application number: M017 kirkland signature hydrocortisone plus maximum strength HYDROCORTISONE Costco Wholesale Company 481341c5-db1f-43fb-aed7-f40495a4eab8 2024-09-29 Warnings Exact identifier application number: M017 Care One hydrocortisone maximum strength HYDROCORTISONE American Sales Company 32593229-d0ac-4d6c-831a-089fc6e76152 2024-09-29 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