Home NDC 61594-044 Theraworx PM Nighttime Maximum Strength Pain Relief
Product NDC 61594-044
11-digit product format 615940044
Labeler code 61594
Product ID 61594-044_5d4f6c02-183f-001e-e063-6294a90a3b80
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 2024-09-01
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 PM Nighttime Maximum Strength Pain Relief
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 61594-044-00 Theraworx PM Nighttime Maximum Strength Pain Relief 1 in 1 CARTON LIQUID 1 2 61594-044-00 Theraworx PM Nighttime Maximum Strength Pain Relief 74 mL in 1 BOTTLE LIQUID 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61594-044 THERAWORX PM NIGHTTIME MAXIMUM STRENGTH PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.] 2 Current NDC, 2 package rows 20240921_bc8cb476-9a47-47b3-ad78-a6ecec9ee66f.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 113 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Medicated Foot Powder MENTHOL Veridian Healthcare 2916a0c3-2d66-d079-e063-6394a90acd6b 2024-12-12 Warnings Exact identifier application number: M017 Ease Your Pain MENTHOL Proximity Capital Partners LLC dba Asutra 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4 2024-12-12 Warnings Exact identifier application number: M017 Natural Seal Itch Relief for Kids LIDOCAINE Kericure Inc. 31cc0c95-5864-4737-b085-8f58e00f4f05 2024-12-12 Warnings Exact identifier application number: M017 Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula HYDROCORTISONE ACETATE Combe Incorporated 9b69fa24-02dd-43e4-a81f-9a37968d7099 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Medicated Creme Maximum Strength BENZOCAINE AND RESORCINOL Combe Incorporated bb73ebd7-ceb0-4b54-9e8f-77486d9037fb 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Creme Regular Strength BENZOCAINE AND RESORCINOL Combe Incorporated dd303ff8-0deb-4292-bfd8-5bda91f86d51 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Medicated Wipes Maximum Strength PRAMOXINE HYDROCHLORIDE Combe Incorporated b848f53d-8aea-4efe-aa2c-009d5121fc33 2024-12-12 Warnings Exact identifier application number: M017 Walgreens Cool and Heat MENTHOL 16% Walgreens ce1585f4-ca65-8d0c-e053-2995a90a8e89 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Cool n Heat LIDOCAINE 4% Walgreens ce1b21d6-7aa6-2b18-e053-2995a90a4c91 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Pain Burn Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Walgreens cc6e4b42-fdd8-6ff7-e053-2995a90a3d1d 2024-12-11 Warnings Exact identifier application number: M017 Pramoxine Itch relief PRAMOXINE HCL 1% CVS e947694c-c122-0291-e053-2995a90ac39a 2024-12-11 Warnings Exact identifier application number: M017 Arthritis Cream TROLAMINE SALICYLATE 10% CVS d1663f50-479b-4d55-e053-2995a90a223f 2024-12-11 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS d1660d55-1ee0-7aa2-e053-2995a90a6579 2024-12-11 Warnings Exact identifier application number: M017 CVS Muscle Rub MENTHOL 10%, METHYL SALICYLATE 15% CVS Health c72c9a95-4226-6d69-e053-2a95a90a8e1c 2024-12-11 Warnings Exact identifier application number: M017 BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Kenvue Brands LLC 0a41ec65-bd0b-4fc6-807d-74f353341cc7 2024-12-11 Warnings Exact identifier application number: M017 Serum X LIDOCAINE HYDROCHLORIDE AO Biologix, LLC e07b6268-6400-6849-e053-2a95a90a8b3e 2024-12-11 Warnings Exact identifier application number: M017 PlusCBD Pain Cream (Penetrating) 2oz CAMPHOR, MENTHOL CV Sciences, Inc. ca39d327-6bf3-3408-e053-2a95a90af2d5 2024-12-11 Warnings Exact identifier application number: M017 Blistex Medicated DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL Blistex Inc. e95439d3-f12b-4c1c-999a-79f2ddba4cfb 2024-12-11 Warnings Exact identifier application number: M017 Blistex Foille Medicated First Aid BENZOCAINE AND CHLOROXYLENOL Blistex Inc. e2eca808-e97b-43e0-aa51-7025cc61c7a8 2024-12-11 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE J&A Digital Inc. ff95a536-35b3-4006-b43c-cce359e86aa9 2024-12-10 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 61594-044-00 61594004400 1 BOTTLE in 1 CARTON (61594-044-00) / 74 mL in 1 BOTTLE 1 bottle 2024-09-01 No No Current